Podcasts about ivd

  How familiar are you with partnerships and collaborations between the laboratory and the diagnostics industry? In this episode Luis is joined by Dr. Andrea Prinzi and Dr. Kristen Smith to explore how partnerships between clinical labs, public health institutions, and the diagnostics industry drive innovation in in-vitro diagnostics (IVDs).  What is the IVD pipeline? From discovery to product launch and beyond, these collaborations improve patient care, accelerate access to new technologies, and enhance public health outcomes. Why breaking silos and fostering inclusive partnerships is essential for the future of diagnostics? Tune in to find out.  Link to article: https://doi.org/10.1016/j.clinmicnews.2025.04.001 Questions? Feedback? Send those to letstalkmicro@outlook.com Want to support the podcast? Here's how: Venmo: https://venmo.com/u/letstalkmicro Buy me a Ko-fi: https://ko-fi.com/letstalkmicro  

Lifestyle-related illnesses, an ageing population and personalised health are some of the medical industry's growth drivers. Manufacturers are using digital technology, from digital dental labs to polymorphic moulds, to win orders and battle tough trading conditions. Will Stirling reports. Over 5.8 million people in the UK are living with diabetes, the highest number on record. The prevalence of type 2 diabetes has nearly doubled in the last 15 years, linked to lifestyle factors such as obesity and high-sugar diets. People are living longer and require mobility and care technology for extended periods. This exemplifies a growing and concerning burden on the NHS, while also presenting a significant business opportunity. The manufacture of hard medical products – surgical instruments, tooling, prosthetics, orthotics, and devices like wheelchairs and beds – encompasses a broad range, particularly when including consumable devices such as single-use plastics. ‘MedTech' typically refers to medical products with embedded digital technology, which includes diagnostic and monitoring devices. However, as more smart medical technology is developed, the division between machined or moulded parts and ‘digital tech' is becoming increasingly blurred. The UK MedTech industry has an annual turnover of £27.6 billion, placing it just behind the aerospace sector (about £30bn). The UK exports £10.1 billion worth of MedTech products annually (2023), but it still faces a trade deficit of £5.4 billion as imports exceed exports. High tariffs on UK-manufactured goods traded with the US increase pressure on this deficit, but there may be a twist. UK medical devices are subject to a flat 10% tariff, which is significantly lower than the high tariffs imposed on Chinese, Asian, Canadian, and Mexican imports, potentially benefiting some UK device exports. The NHS spends up to £18bn annually on medical equipment, consumables, and MedTech—everything from syringes to MRI scanners, a vast domestic market for UK designers and manufacturers to access. So, it's little surprise that it's rich with engineering and business innovation. MedTech is being affected by the same trends as other manufacturing segments: digital technology, sustainability, cost reduction pressure, new materials, and new or fast-developing manufacturing technologies. 3D printing and polymorphic moulding are used increasingly in device manufacturing, such as in Prosthetics and Orthotics, aka ‘PO', and specialist CAD/CAM software is utilised for digital dental manufacturing. The PO industry is worth £274m in 2024. Growth in prosthetics is fueled partly by amputations related to type 2 diabetes, and in orthotics by child mobility and disability needs. About 260 businesses operate in the PO sector, which surprisingly has 24% higher productivity compared to the entire healthcare sector (Source: BHTA, Healthtech's economic impact in the UK). Light the Fyous Orthotics are externally applied devices used to influence the body's function. They can be applied across the body but are most used to support the feet and lower legs. Foot orthotics are custom-made supports for the patient. Here, conventional mould tools used to make a plastic mould are uneconomic—short-run batches don't cover the tool cost. Fyous, the Sheffield-based polymorphic moulding technology provider, uses a proprietary pin tool with 28,000 pins to create a customised, ‘shapeshifting' mould in around 20 minutes. It recently partnered with Peacocks Medical Group, the UK's largest independent orthotics company, to use the polymorphic technology for its products. “This collaboration shows how polymorphic moulding can help the production of lasts (foot orthotics), cutting waste and costs, and improving efficiency,” said Joshua Shires, CEO and Co-Founder of Fyous. “Early adopters like Peacocks will gain a competitive edge as the industry moves towards more sustainable, digital-first manufacturing.” Fyous is now developing its pin technology to address the diabetic foot care market, where the NHS spends nearly £1bn a year on diabetic care. Several British MedTech companies are attracting big investments. In April, Cambridge-based robotics company CMR Surgical closed a US$200m funding round with a mix of equity and debt capital from investors Trinity Capital. The funds will be used to expand CMR's flagship Versius Surgical Robotic System to more hospitals globally, with a focus on the US market, and to support the launch of the enhanced Versius Plus. In 2021, CMR's private funding pushed above £1bn, valuing the company at $3bn. “We are now at a pivotal stage, poised to capitalise on significant opportunities for market expansion, including in the U.S, while penetrating deeper into expanding markets,” says CEO Massimiliano Colella. Cutting into the booming digital dental market Digital technology has allowed the production of dental implants and restorations to change rapidly. Today, many digital manufacturing labs can provide uber-accurate dental implants, crowns, and tooth sets in multiple materials in quick delivery times from 3D models of teeth supplied by dentists. These labs need the best milling tools to machine these implants accurately. Nine months ago, dental lab Optadent contacted high-precision tooling company Quickgrind to supply a two-flute, ball nose tool with 5mm extra reach. Optadent was compromising its CNC machining strategies; Managing Director Anthony Wainwright felt this could be improved by moving from standard tools from dental consumable distributors, to using a bespoke manufactured tool. Quickgrind's Total Solutions Engineering Strategy, a custom-made tooling service, was a perfect match. Material versatility is key in dental implants, and these tools are designed to machine the main specialist dental materials – chrome cobalt, titanium, zirconium oxide, PMMA, PEEK and wax. This engagement showed Quickgrind a relatively new and booming global, digital business – an industry within an industry. “Since spotting the opportunity we have worked closely with digital machining dental lab owners & technicians, machine tool manufacturers, machine tool distributors, CAD/CAM developers, CAD/CAM resellers, CNC application engineers and academics, to build our knowledge and understand how the market is growing and what may limit the speed of growth,” says Technical Support Manager Mark Aspinall. You can read the full story on page 52 and 53. Hold your nerve and keep innovating Amies is a 96-year-old, family-owned injection moulded component and assembly manufacturer. Over the last 20 years, the company has steadily built its medical business so that it now exceeds 50% of turnover across a diverse customer base in medical devices and IVD products. “Over our long history, we have learned that the best strategy is to maintain a solid and reliable technical base, such as the fleet of modern Arburg IMM machines we operate, while keeping fully aware of new technologies and materials as they develop, with a view to early adoption,” says Managing Director Simon Stewart-Smith. As regards innovation trends, Amies is increasing its use of in-house additive manufacturing in the development phases of medical projects and even most recently, some early pre-series production runs of complete assemblies. There is a lot of interest in eco-materials, too. “We are delighted to be engaged in some exciting, top-secret projects around a promising bioplastic that are progressing well,” Simon adds. “We are all operating in a challenging environment now, with many challenges coming from changes imposed by governments both home and abroad, but there is every reason to be optimistic that by remaining agile and focused, we can remain strong and continue to steadily grow.” Tariffs and turbulence put the brakes on medical's potential Like other sectors, medical devices face troubling conditions, not only US tariffs causing mayhem in supply chains. “The MedTech and HealthTech sectors currently face an unprecedented array of challenges; employers' NI increases, trade tariffs, regulatory uncertainty, post-Brexit trading status with the EU, NHS reform, the need for social care reform, the list goes on!” says David Stockdale, CEO of the British Healthcare Trades Association. “With so many moving parts and burdens placed on these sectors, it is an incredibly challenging market to be in. That said, there are opportunities, as innovations come into the market, coupled with an ageing population, there is growth potential here – it is just hard to see amid all the turmoil. It is important that the government better understands the sectors, who to support and to work with them at this time to help them flourish.”

Welcome to the electrifying world of drum and bass with the Stress Factor Drum and Bass Podcast episode 323, featuring the unparalleled DJ B-12. Celebrating 15 years of online excellence, this episode marks his second stunning studio mix for March 2025. Prepare to be transported on a transcendent journey as DJ B-12 masterfully blends an array of styles, showcasing his signature sound that has captivated listeners for over a decade and a half. This mix is not just a collection of tracks: it's an experience that resonates deeply, inviting you to lose yourself in its sexy rhythm and energy. With a remarkable runtime of just over 2 hours, this episode features an impressive 75 tracks that span the spectrum of drum and bass. From uplifting and soulful beats to the cutting-edge sounds of electro, progressive and liquid DNB, DJ B-12 has curated a set that is both diverse and cohesive. Each transition is seamless, each drop is exhilarating, and the overall flow is nothing short of breathtaking. This mix is a testament to his artistry, showcasing not only his technical skills but also his deep understanding of the emotional power of music. Whether you're a long-time fan of drum and bass or a newcomer eager to explore, this episode is a must-listen. DJ B-12's ability to weave together various elements of the genre creates a rich tapestry of sound that is both uplifting and introspective. Experience the beauty and depth of this stunning mix, and let it take you on a spiritual journey that only DJ B-12 can provide. Don't miss out on this incredible auditory adventure, tune in and elevate your listening experience today! This episode contains, track and remixes by the following artists and on the following labels: Jessee, Ayah Marar, DeVice, Genetics, Ridmic, Subkey, Fokuz Recordings, Solid State, Joy Doc, SUBBWELL, Alcemist, Pola and Bryson, DnB Allstars, Subsonic, Task Horizon, The Velvet Effect, Eatbrain, Artino, Sam Welch, Liquicity Records, Rusko, Monstercat, Cream Blade, romi, Natty Lou, Gemma Rose, Future, Matt View, Sem, Macknote7, Daniel Tales, Guena Music, 1991, IVD, Armada Music, Lee Mvtthews, Elevate Records, James Hiraeth, Rinse, KOOL, 3xil3, Neuropunk Records, Chrissie Huntley, A Little Sound, S.P.Y, CMD CTRL, Ministry of Sound Recordings, Technimatic, Spearhead Records, ALB, UKF, FinnaDrift, Messjilla, Goldfat Records, Monrroe, Let It Roll, Lexurus, Kaskade, Punctual, Poppy Baskcomb, DNMO, Monstercat, MODUS, Tiesto, Koven, Musical Freedom, INVOLVER, Soulvent Records, Paolo Tossio, Mario Tossio, Paolo Tossio Productions, Paige Cavell, Goddard., Positiva, Beyond Me, Lizplay Records, The Prototypes, Roadblock Records, T and Sugah, High Tea, ICONS, Manifest, Bloque, Keylo, Impish, Occulti Music, LSB, Etherwood, Footnotes, MusicbyAden, LVX, Shattered Nights, Subkey, Rex Hooligan, Mojoman, Beatalistics, Bailey, SUNANDBASS Recordings, Michael Calfan, S.P.Y, Dipping Sauce, Nastja Po, Sigma, Mali Koa, Day Ones, shadre, SALVAGE, Audio Suicide Recordings, Audien, Fred V, Oaks, Armada Music Albums, hayve, DRIIA, Twintone , AIRGLO, BEACON, Caleo, Deeper DNB, Drea Perlon, Forteba, AEYA Records, Natty Lou, Leemo (UK), Faye Derbyshire, Bitsune, M'Go, Lya, Manifestm, 5X, Inverse Records, Xetao (JP), MellowGang, Method, Culture Shock, Grafix, sadHAPPY, Culture Shock Music, Blean, Bloque, Interstellar Audio, Wilkinson, Julia Church, Sleepless Music Ltd., T and Sugah, HEXAGON, Andromedik, Imallryt, GNTLMAN, High Resistance, Circadian, Nu-La, Freaks and Geeks, Sub Focus, bbyclose, Gourski, Zombie Cats, Voicians, Velodic, 3LAU, Krakota, Anjunabeats, and ShockOne. Tracklist 01. Jessee - The Ones feat. Ayah Marar [DeVice] 02. Genetics - Losing Control [Ridmic] 03. Subkey - Stratos [Fokuz Recordings] 04. Solid State Ft. Joy Doc - Better Without [DeVice] 05. SUBBWELL - Away from You [Subbwell] 06. Alcemist - Us (Pola and Bryson Remix) [DnB Allstars] 07. Subsonic - Wait For Me [DnB Allstars] 08. Task Horizon and The Velvet Effect - Outrunning Dawn [Eatbrain] 09. Artino and Jessee - Bring The Rain (ft. Sam Welch) (Extended Mix) [Liquicity Records] 10. Rusko - Rubix Cube [Monstercat] 11. Cream Blade and romi - Celestial (Last Time) [Ridmic] 12. Natty Lou - Close To Me (ft. Gemma Rose) [Future] 13. Matt View - Come Clean [Ridmic] 14. Artino - Way Out feat. Sem [Liquicity Records] 15. Macknote7 - Neowise (Daniel Tales Remix) [Guena Music] 16. 1991, Subsonic and IVD - Castles In The Sky (Extended Mix) [Armada Music] 17. Lee Mvtthews - Ready 4 It [Elevate Records] 18. James Hiraeth - Glitter and Gold [Rinse KOOL] 19. 3xil3 - Satellites Fall [Neuropunk Records] 20. Artino Ft Chrissie Huntley - Insight [Elevate Records] 21. A Little Sound, S.P.Y and CMD CTRL – Area Code (Extended) [Ministry of Sound Recordings] 22. Technimatic - From Within [Spearhead Records] 23. ALB - Cold Hearted [UKF] 24. FinnaDrift - Midnight Sip of Water ft. Messjilla [Goldfat Records] 25. Monrroe - Imprisoned [Let It Roll] 26. Lexurus - Close To You [UKF] 27. Kaskade and Punctual - Heaven Knows (feat. Poppy Baskcomb) (DNMO Remix) [Monstercat] 28. Artino - Introspection [MODUS] 29. Tiesto and Poppy Baskcomb - Drifting (Koven Remix) [Musical Freedom] 30. INVOLVER - Colours [Soulvent Records] 31. Paolo Tossio - Weeping Angel (feat. Mario Tossio) [Paolo Tossio Productions] 32. Paige Cavell and Goddard. - Owe It All To You [Positiva] 33. Beyond Me - La fleur [Lizplay Records] 34. The Prototypes - Feed My Soul [Roadblock Records] 35. T and Sugah - Louder [High Tea] 36. ICONS - Paradise [Manifest] 37. Artino - World Of Lights [Liquicity Records] 38. Bloque and Keylo - Better Day [Ridmic] 39. Impish - Truth Is (Vinyl Version) [Occulti Music] 40. LSB and Etherwood - Evermade [Footnotes] 41. MusicbyAden and LVX - Retreat [Shattered Nights] 42. Subkey - Aozora [Fokuz Recordings] 43. Rex Hooligan - I'm Always Dreaming About You [Ridmic] 44. Mojoman - Tanelty [Beatalistics] 45. Bailey - Letter From Detroit [SUNANDBASS Recordings] 46. Genetics - Let You Go [Ridmic] 47. Michael Calfan - Treasured Soul (S.P.Y Remix) [Dipping Sauce] 48. Nastja Po - My Home (Daniel Tales Remix) [Guena Music] 49. Sigma - CHEMICALS Ft Mali Koa (Extended Mix) [Day Ones] 50. shadre and SALVAGE - Escalate [Audio Suicide Recordings] 51. Audien and Fred V feat. Oaks - Cold (Extended Mix) [Armada Music Albums] 52. hayve - What Are We Proving (feat. DRIIA) [Monstercat] 53. Twintone - The Encounter [Beatalistics] 54. AIRGLO - Raindrops [BEACON] 55. Caleo - Away [Deeper DNB] 56. Drea Perlon and Forteba - Better Without You [AEYA Records] 57. Natty Lou, Leemo (UK) and Faye Derbyshire - Think Of U [Ridmic] 58. Bitsune, M'Go, and Lya - On My Head [Manifest] 59. 5X - All I Knew Was You [Inverse Records] 60. Xetao (JP) - Summer Days [MellowGang] 61. Method - No More Us [Ridmic] 62. Culture Shock and Grafix - Giants (Ft. sadHAPPY) [Culture Shock Music] 63. Blean and Bloque - Hostility [Interstellar Audio] 64. Wilkinson - Back To Life (feat. Julia Church) [Sleepless Music] 65. T and Sugah - Sky [HEXAGON] 66. Andromedik - Running (ft. Imallryt) [Liquicity Records] 67. GNTLMAN - Voices [High Resistance] 68. Circadian and Nu-La - Rebirth [Elevate Records] 69. Freaks and Geeks - Oxygen [UKF] 70. Genetics - Phoenix [Ridmic] 71. Sub Focus and bbyclose - On & On (Extended Mix) [Positiva] 72. Gourski and Zombie Cats - INTRUDERS [Zombie Cats] 73. Voicians - Lost (Extended) [Velodic] 74. 3LAU - Easy feat. XIRA (Krakota Remix) [Anjunabeats] 75. ShockOne x Lee Mvtthews - Thinkin About (T and Sugah Remix) [UKF]

„Politik ist kein Wunsch-Konzert“: So kann man das auch sagen. Mit IVD-Präsident Dirk Wohltorf habe ich über die Bundestagswahl gesprochen, über Deals in Koalitionen, über die einzelnen Parteien. Und über seine Kritik, dass Eigentum kein Elitethema sein darf. Wir sprechen über den Fach- und Sachkunde-Nachweis für Politiker, über das Bauministerium, das es wohl nicht mehr geben wird. Es geht um grün-linke Kampagnen und warum es die Immobilienbranche nicht schafft laut zu sein. Dirk Wohltorf macht sich zudem Sorgen, wie die Themen der Branche in die Bevölkerung kommen, Ehrlichkeit sei das, was Akzeptanz schaffe. Es müsse wieder Vertrauen von allen Seiten aufgebaut werden. Mietpreisbremse: ein Thema, das Dirk Wohltorf nicht mehr hören kann. Den Schlamassel, den sie gebracht hat, sehe man jetzt. Warum Politiker das immer noch nicht verstanden haben, versteht er wiederum nicht. Und zum Schluss muss es natürlich um Hertha BSC gehen, die gerade eine schlechte Saison haben. Für den gebürtigen Berliner und Fan nicht gerade schön.

Was sagen die einzelnen Parteien über das Thema Immobilien in ihrem Wahlprogramm? Das besprechen Marco, Gründer von immocation, und Jürgen Michael Schick, Immobilienunternehmer und ehemaliger Präsident des IVD. Wie sieht es mit dem Wohnungsbau in der Zukunft aus? Kann eine Mietregulierung auf uns zukommen? Bei welchen Parteien wird über Mietwucher diskutiert? Was bei der energetischen Sanierung auf uns zukommen könnte und welche Prognose die beiden abgeben, das erfahrt ihr in dieser Folge. immocation. Lerne Immobilien.

„Hier ist noch das Land von Milch und Honig“: Ja, richtig gehört. Swen Nikolaus und Christian Hoffmann haben den globalen Blick. Amerika hat eine doppelt so hohe Inflationsquote, 67 Prozent sind es in der Türkei, dazu gibt es eine massive Abwertung der Währung. Die Deutschen verstünden es sehr gut sich selbst schlecht zu machen. Es gebe aber jetzt wieder eine gute Basis, um sich für die Zukunft aufzustellen. Die Zukunft von Swen und Christian begann schon 2023, denn da unterschrieben sie einen Vertrag mit Keller & Williams, brachten damit das amerikanische Maklernetzwerk nach Deutschland. Weltweit sind darin über 200.000 Makler in über 60 Ländern organisiert. Swen und Christian sprechen mit mir über Transparenz und Miteinander als Grundlage für das Netzwerk, über die Internationalität innerhalb Deutschlands, Strukturen, Prozesse und Ineffizienzen. Es geht um das Image der Makler, die Kooperation mit dem IVD, um die Nachweispflicht für die Kompetenz eines Maklers und Lokalität. Ebenfalls erwähnenswert: der schöne Ryan Gosling, Reisen in mehr als 100 Länder, Süßigkeiten, das Dreamteam und die Rose am Revers. Ein Blind Date also für die Immobilienbranche.

Medboard EU EU MDR and IVDR article 10a - Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods - Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdfEUDAMED EMDN: UPDATE or not to UPDATE - MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities - Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 - Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices - Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html UK timeline for UKCA - Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance - Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type   TUK Vigilance Reporting - Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems   UK guide for IVD - Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training - Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ - Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia - Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test - Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia - What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration - Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices - For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 - Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists - List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 - How to register a Medical Device in South Africa - Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 - How to perform your PMS for a Drug-Device Combination - Joan D'Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 - Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 - 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/

Bienvenue sur IVD – Individus Voulant Danser. Cette émission diffusée sur @radio-campus-angers animée par Le Tatus du So6 CROU met en… The post IVD#006 – Midnight Sun – 23.01.2025 first appeared on Radio Campus Angers.

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where  pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa.  Who is Khanyisile Nkuku?  Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration  Officer  at the South Africa Competent Authority (SAHPRA) ,  she contributes her expertise in the assessment and registration of medical devices & IVD's in South Africa  to promote medical device & IVD access on a global scale, with a particular focus on African countries. She holds a Bachelor of Pharmacy  honours degree ,a Master's in Pharmacy administration & Policy Regulation ,  and is currently busy with Masters in Business Administration in Healthcare Leadership . She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening.  Having great strength in policy advocacy, policy development, policy implementation and compliance. She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF)  technical mainly the MDA-TC ( Medical device Assessment Technical committee  member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees . Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Khanyisile Nkuku LinkedIn:  http://linkedin.com/in/khanyisile-nkuku-975663a9 SAHPRA Website: https://www.sahpra.org.za/medical-devices/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Bienvenue sur IVD – Individus Voulant Danser. Cette émission diffusée sur @radio-campus-angers animée par Le Tatus du So6 CROU met en… The post IVD #002 – S-006 – 28.11.2024 first appeared on Radio Campus Angers.

Bienvenue sur IVD – Individus Voulant Danser.  Cette émission animée par Le Tatus du So6 CROU met en lumière des… The post IVD#001 – Le Tatus – 14.11.2024 first appeared on Radio Campus Angers.

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.*

In dieser Episode von Maklergeflüster sprechen wir mit Jeanette Kuhnert, Geschäftsführerin von Wittlinger & Co. und Vizepräsidentin des IVD. Jeanette gibt spannende Einblicke in ihre Karriere, den Immobilienmarkt und ihre Arbeit im Gewerbe- und Investmentimmobiliensektor. Wir diskutieren die Bedeutung der Expo Real, aktuelle Trends in der Branche und die Herausforderungen, die die Zinswende mit sich gebracht hat. Außerdem beleuchten wir ihre Rolle im IVD, die Zukunft der Immobilienbranche und geben wertvolle Ratschläge für junge Berufseinsteiger. Viel Spaß beim Zuhören! - Wunderschöne Grundrisse und Visualisierungen: www.mcgrundriss.de  Zu Wittlinger & Co.: https://www.wittlinger-co.de/  Zum IVD: https://ivd.net/ 

Heute zu Gast: Nils Werner. Er spricht über seinen Werdegang, die Herausforderungen und Motivationen von Immobilienmaklern, die Fehler, die in der Branche häufig gemacht werden, sowie die Bedeutung von digitaler Affinität und Kreativität in der Selbstständigkeit. Zudem sprechen wir über die Zukunft der Immobilienbranche und die Vorteile von Immobilieninvestitionen. Takeaways Nils Werner hat einen bewegten Lebenslauf von der Marine zur Immobilienbranche. Selbstständige Immobilienmakler suchen oft nach Freiheit und Selbstbestimmung. Die letzten zwei Jahre waren für viele Immobilienmakler herausfordernd, besonders für Neueinsteiger. Kreativität und Technologieoffenheit sind entscheidend für den Erfolg in der Immobilienbranche. Die Komplexität des Immobilienmarktes erfordert eine umfassende Qualifikation. Einzelkämpfer-Tum ist ein Auslaufmodell; Kooperation ist wichtig. Digitale Affinität ist entscheidend für den Erfolg von Immobilienmaklern. Immobilieninvestitionen sind eine gute Möglichkeit, Vermögen aufzubauen. Der IVD bietet zahlreiche Dienstleistungen für Immobilienmakler an. Der Hauptstadtkongress des IVD am 15.10.2024 ist eine wichtige Veranstaltung für die Branche. Chapters 00:00 Vorstellung und Hintergrund von Nils Werner 09:38 Motivation zur Selbstständigkeit in der Immobilienbranche 11:03 Herausforderungen und Learnings der letzten zwei Jahre 15:56 Fehler und Herausforderungen für Immobilienmakler 17:56 Zukunft der Immobilienmakler und digitale Affinität 19:50 Immobilieninvestitionen und persönliche Erfahrungen 21:42 Einladung zum Hauptstadtkongress und Abschluss Keywords Immobilien, Selbstständigkeit, Herausforderungen, Fehler, digitale Affinität, Immobilieninvestitionen, IVD, Nils Werner, Unternehmer Podcast

Would you go under the knife to achieve the body you want? Or take a weight loss pill that comes with huge risks? Richie Brave and his guests, Justin Mob and Harmony from The Cosmetic Lane, Teacher from Birmingham Petra, rapper IVD and 1Xtra family Nadia Jae discuss cosmetic procedures and body confidence. Plus, hear stories from those who have taken different routes to achieve their body goals. @1Xtra on social

Join us for the third episode of Incarceration month where we discuss Tammy's pick of The Shawshank Redemption and answer questions like:TBS or TNT?Is this a Highlander prequel?andWhat's an IVD?Learn all about Quad Pro Quo at: https://linktr.ee/quadproquopod

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices. -------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.  Who is Martin King?  Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceuticals since 1979. Martin is a leading expert in quality assurance, regulatory compliance, and product development, developing active wearable devices since the 1980s.  Known for his hands-on approach and deep understanding of complex regulatory environments, Martin has guided companies around the globe through successful regulatory submissions. His expertise spans across six continents, making him a sought-after advisor in his field.  Martin holds advanced degrees in Micro-electronics and Materials Science, and Electronic Engineering. He is a trained Lead Auditor for ISO 13485:2016 and is well-versed in international standards such as 21 CFR 820 and MDR 745/2017. Recognized as one of the top 25 MedTech Leading Voices on LinkedIn, Martin also shares valuable insights through his popular weekly regulatory roundup.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Martin Kings LinkedIn: https://www.linkedin.com/in/martink2/  QARA Whatsapp group: https://chat.whatsapp.com/Dkl3XrjiXzW51Fgipf96k2  QARA Whatsapp channel: https://whatsapp.com/channel/0029VaaBTj9CxoAwG0CUBn1x  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Günter joined Tecan in 2003 as Senior Vice President, Head of Quality Assurance and Regulatory Affairs. He has been a member of the Management Board from 2003 to 2010 and a member of the Extended Management Board ever since.Günter has over 35 years of experience in the in-vitro diagnostics and medical device industry. He ensures successful strategies for commercialising products worldwide with his team and Tecan's customers. Günter is an expert in the implementation and certification of quality management systems in MedTech and IVD companies and a certified enterprise risk manager.Tune in for:How to adopt a business-first mindsetWhat QARA teams can do to build trust with business partnersHow to align QARA goals with the wider businessAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.

This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by ⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠ ⁠⁠at RQMplus.com. Thank you for tuning in.

Our ongoing educational video series on

In this episode of Behind the Numbers, Dave Bookbinder hosts an engaging conversation with Chris Strohsahl, the President and CEO of Drummond Scientific Corp. The discussion offers deep insight into Drummond's vital role in the global medical device industry, their unique approach to impactful solution creation, and the immense importance of nurturing meaningful client relationships. Chris shares captivating details of his journey, moving from biophysics to leading Drummond Scientific Corp in developing and investing in life-saving medical devices. He sheds light on their mission of making a difference beyond just product production, from helping families conceive to assisting individuals manage crucial health conditions. He further explores the challenging journey a product takes before hitting the shelves, and Drummond's key role in scaling these devices to ensure broader accessibility. Stressing on the need for forming strategic partnerships, Chris emphasizes the vital responsibility of supporting customers in the design process, thereby securing the viability of their innovative solutions at scale. The team also scrutinises the impact of the COVID-19 pandemic, reinforcing the significance of flexibility and adaptability in preserving business operations and supply chain management. In the concluding section of the episode, they discuss the vital role and the value of efficacy of a management team, underscoring the essence of the team's synergies and collective competencies in an organization. Chis outlines the value of failure as an entrepreneur, emphasizing its role as a tool for understanding one's potential and fostering success. The significance of networking, building sustainable relationships, and running startups are other invaluable nuggets shared in this insightful discussion. As an Angel Investor, Chris advises focusing beyond a startup's monetary value, instead, keeping an eye on the people and mission behind it. About Chris Strohsahl: Chris Strohsahl is the President and CEO of Drummond Scientific Company. A biophysicist by training, with expertise in the innovation of diagnostic techniques and devices, he rose to Drummond's top position at the start of 2022 and has since led the Company's rebranding as an elite manufacturing partner to both leaders and disruptors in the IVD and IVF industries. A passionate believer that medical device development works best when end-stage manufacturing is engaged early, Chris and his colleagues have driven a paradigm-shift at the Company, as Drummond now actively seeks to engage its partners far earlier than would be expected of a typical high-throughput manufacturer. About Our Sponsor: Haefele Flanagan (HFCO) is a full-service accounting firm that's been serving clients since 1967.  Not your typical accounting firm, HFCO's services extend well beyond tax and audit to include valuation services, strategic and succession planning, leadership development, and more.  When you work with Haefele Flanagan, we help you realize your long-term goals.  Please visit them at www.hfco.com. About the Host: Dave Bookbinder is the person that clients reach out to when they need to know what their most important assets are worth. He's a corporate finance executive with a focus on business and intellectual property valuation. Known as a collaborative adviser, Dave has served thousands of client companies of all sizes and industries.  Dave is the author of two #1 best-selling books about the impact of human capital (PEOPLE!) on the valuation of a business enterprise called The NEW ROI: Return On Individuals & The NEW ROI: Going Behind The Numbers.  He's on a mission to change the conversation about how the accounting world recognizes the value of people's contributions to a business enterprise, and to quantify what every CEO on the planet claims: “Our people are this company's most valuable asset.”  

  EUROPEEU MDR 26 May 2024 - Was there any apocalypse: France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320 EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf EU talks about SoHo -: Substances of Human Origin https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356 https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/ Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569 Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8 Combined Studies in the EU - COMBINE PROJECT: https://ec.europa.eu/newsroom/sante/items/830485/en https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf Notified Bodies Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf New Notified Bodies for EU MDR – MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1 Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18 QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1   UKUK on international recognition - Approve products without CE or UKCA mark:  https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217   Easy Medical Device: eQMS SmartEye Video: One of the best eQMS for Medical Devices  One of the best eQMS for Medical Devices   Events:Medtech Conf: Title: International Medical Device Exhibition and Conference - Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/   Training Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/ EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/   WORLDUSUS Remanufacturing or Servicing  - Webinar replay included: https://www.fda.gov/media/150141/download Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024 US - Use of Patient Generated Data - Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case US Laboratory Developed Tests - Final rules defined and Webinar to explain: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024 https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests Australia Australia - in-house IVDs requirements - Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf Saudi Arabia Saudi Arabia - Webinar Biological Evaluation - 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404 NigeriaGuidance to register Medical Devices - Registration, labelling and advertising: https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf India CDSCO laboratory testing - But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg= Malaysia Malaysia Guidance for Medical Device - Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device Hong-Kong Overview of a Local Responsible Person - Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf Singapore  Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md   PODCASTPodcast Nostalgia - What topics were discussed Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/ Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/ Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/ Episode 286: Summative Evaluation - Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/      

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability.  Who is Amandine Broussier ? Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD).  Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.      Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link  Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/  IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html  IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html  IEC 62366-2: https://www.iso.org/fr/standard/69126.html  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions.  Who is Vincent Cafiso ?  Named as one of MD+DI's 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/  CREO Consulting Website: https://creoconsulting.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Wie ist die aktuelle Marktlage und was sind die Trends in der Zukunft? Das weiß Jürgen Michael Schick, Immobilienunternehmer und ehemaliger Präsident des IVD. In diesem spannenden Interview möchte Marco, Gründer von immocation, gerne wissen, wie sich die Inflation entwickelt und wie aktuell die Auswirkung auf den Immobilienmarkt ist. Brauchen wir in Zukunft mehr Wohnraum und wie sehen faire Mieten aus? Wie sieht die Entwicklung bei Eigentumswohnungen, MFH und großen Wohnungspaketen aus? Einen Rundumblick der aktuellen Marktlage bekommt ihr in dieser Folge. Außerdem gibt unsJürgen Michael Schick einen Einblick in seine eigene Investitionsstrategie. immocation. Lerne Immobilien.

EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1 MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx  Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=      Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/  Spain AEMPS Bulletin on Health Products –  From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan  Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html  Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706   Article to read European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf   Training Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/  Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI Team-NB training  -  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/   Events  Events –  Check Medtech Conf: https://MedtechConf.com   Rest of the world  South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do  South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)  South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1  Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0  Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats   Podcast  Radiation Sterilisation Master File   -  Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/  What is the impact of AI Act on Medical Devices –  Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/  Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/      

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠completing the form on this page⁠⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠Knowledge Center⁠⁠⁠ or ⁠⁠⁠Events⁠⁠⁠ pages at RQMplus.com. Thank you for tuning in.

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry. Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a Positive Team Culture and Avoiding Arrogance 19:12 The Philosophy Behind Prodct: Focusing on Medical Devices 20:55 A Personal Touch: The Impact of 'Born to Run' 21:59 Closing Thoughts and Where to Find Devon Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks[00:25:50] - Impact of regulatory changes on labs and manufacturers[00:40:10] - Detailed exploration of user needs and design controls in IVD development[00:52:00] - Advice for medical device professionals entering the IVD spaceNotable Quotes:"Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie HughesKey Takeaways:Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.References and Resources:FDA decision summaries for recent IVD clearancesEuropean In Vitro Diagnostic Regulation (IVDR) updatesCDRH LearnFDA Proposed Rule for LDTsEpisode on LDTs with Shannon BennettChristie Hughes on LinkedInEtienne Nichols on LinkedInMedTech 101:In Vitro Diagnostic (IVD) Devices: Tools that analyze human samples (like blood or tissue) outside the body, used to diagnose diseases, conditions, or to monitor a person's overall health.Audience Interaction:Discussion Question: "How do you envision IVDs changing everyday healthcare practices in the future?"Call for Feedback:Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics.Special Thanks to Our Sponsor:This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...

 Sponsor: Medboard   EU EU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey - Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf   Spain: AEMPS consultation - Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/ EURL Second Call - More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en TEAM-NB Position Paper - Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/02/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf EMDN Proposal - Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/ MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf   Training Training Green Belt EU MDR - Learn by practicing: https://school.easymedicaldevice.com/course/gb30 Open March 25th, 2024 until March 29th, 2024TEAM-NB Training - Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdfApril 29th, 2024   Services Packaging and IFU - Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/   ROW USA Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device   CANADA Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html   Mexico Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es   Saudi Arabia  SFDA Harmonized Standards - Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf   Qatar  Qatar Telemedicine - Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf   Australia TGA SOPP requirements - System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf TGA Essential Principles - Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls: https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf   https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf   PODCAST Episode 271 - How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/ Episode 272 - Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/ Episode 272 - New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/   EASY MEDICAL DEVICE Services: Training: https://school.easymedicaldevice.com/emd-course/ Authorized Representative EU: https://easymedicaldevice.com/eu-rep/ Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/ Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/ Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/ Eqms SmartEye; https://smart-eye.io Conferences: https://medtechconf.com/  

EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf   MDCG 2024-1 Vigilance System for CE - Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf   Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable: MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf eQMS your eQMS SmartEye - The best eQMS ever:  https://eqms-smarteye.com UK Future Regulation roadmap - We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf Course Training EU MDR Green Belt - February and March 2024 : https://school.easymedicaldevice.com/gb/ Notified Bodies and Approved Bodies UK Approved bodies - They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf   GDP video Good Documentation Practices - Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI ROW USA US FDA Quality Management System Regulation - Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked US FDA IVD Reclassification - Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program Non-IVD: https://www.fda.gov/media/174458/download?attachment IVD: https://www.fda.gov/media/174459/download?attachment eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc   Saudi Arabia Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262   Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf   Events Medtech Conf - RAPS Workshop - Feb 27th until March 1st: https://medtechconf.com/event/raps-events/ Podcast Nostalgia - Relisten again and again Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/ Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/ Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/ Whatsapp Community: Whatsapp community - Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, January 30, 2024. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. RenovoRX closed a $6.1 million private placement. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what RenovoRX is developing and how it wants to spend the funds.  Vicarious Surgical has picked a former Olympus executive as president. Find out who is taking on this role and some of their career history.  ReWalk Robotics rebranded to 'Lifeward' as its portfolio continues to expand. Whooley shares the reason behind the rebrand and what executives are thinking. Globus Medical is laying off 157 employees at the former NuVasive headquarters. Hear more about the reason behind the layoffs and which departments are affected. Philips has discontinued certain CPAP product lines after the ongoing recall saga. The Fast Five hosts talk about the consent decree and how the company came to this decision. BONUS: Read the top IVD and diabetes stories of 2023.

Medboard Who is Medboard Medboard: https://www.medboard.com/ EU  EU Reference laboratories EURL EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en Letter to EU Parliament  Letter sent to the European Parliament - Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INITMDCG 2023-7 on Clinical Investigation MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf MDCG 2019-07 rev 1 on PRRC MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf MDCG 2021-27 on Importer and Distributor MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf MDCG 2023-5 on Annex XVI class MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf MDCG 2023-6 on Annex XVI Equivalency MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf Companion Diagnostics CDx EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf Switzerland Guidance on Devices with no medical purpose Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf Emergency use of non-conform device Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf Notified Bodies: New Notified Body under EU MDR 43rd NB MDR - CESKY METROLOGICKY INSTITUT - Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true Notified Body Situation Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf Training: EU MDR training Green Belt training 28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/ 29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/ 30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/   Medical Device e-Training eTraining Vigilance Reporting:  https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/   ROW Mexico: Mexico registration rules Guide for obtaining the Health Registry of Medical Devices - https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/ Brazil: Brazil is calling Innovative Medical Devices Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto   Hong-Kong: Hong-Kong Guidances Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf USA: USA Export documents transition to digital Transition to Electronic Export Documents - Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry   India: India New platform to register National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=   Australia: Australia Boundary and Combination products guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf Australia on Custom-Made and Patient Match How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf   Malaysia Malaysia is telling rules on Borderline products Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc Malaysia is telling rules for classification of products List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso   Podcast Nostalgia Podcast Nostalgia Episode 262 - What is usability: https://podcast.easymedicaldevice.com/262-2/ Episode 263 - Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/ Episode 264 - Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/ Episode 265 - Heatmap: https://podcast.easymedicaldevice.com/265-2/

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance. » The integral components of quality culture, including an emphasis on resolving issues constructively rather than avoiding them, the crucial role of trust, a shared commitment to quality, and holding each other accountable for outcomes. » How leadership should exemplify and consistently reinforce quality values, impacting trust and openness within the organization. » The challenges in sustaining a quality culture, which underscore the need for ongoing employee engagement and assimilating new staff into the existing culture. » The fact that quality culture isn't static and must evolve with changing internal and external business environments. Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD). His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness. With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.Episode Highlights:IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.Quote:"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen BrownReference Links:Carmen BrownProxima Clinical ResearchGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Medboard Medboard platform  Sponsor of the podcast https://www.medboard.com/ EU EPSCO Meeting November 30th. 2023  -  MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf Survey on Medical Devices -   Study supporting the monitoring of the availability of Medical Devices on the EU Market. Information: https://ec.europa.eu/eusurvey/runner/MFandAR Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96   Falsification of Medical Devices - Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf MDCG 2022-11 Rev 1 Position Paper - Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf EU IVDR Technical Documentation training - TEAM-NB Survey result Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/   DEHP Substance forbidden in Medical Devices - Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482Notified Bodies Situation - 2 new comers: UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true Switzerland Vigilance Reporting submission information  - Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html Training EU MDR Training EU MDR 2017/745 - December 11th - Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27 Medtech Conf Your Medtech Conferences -  Register all your Events, Training, Conferences: https://medtechconf.com/ USA FDA withdrawal - not anymore member of the GHWP: https://www.fda.gov/media/174142/download Discontinuation in the USA - Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download Webinar on Companion Diagnostics - Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023Canada Medical Device Establishment Licenses annual review - You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html Saudi Arabia Webinar: Clinical Trials of Medical Device Requirements - Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098South Africa Guideline on Q&A for Licensing of Medical Device Establishment - Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf Brazil Argentina & Brazil signed a Mutual Recognition Agreement - For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para SmartEye eQMS for Medical Device companies - Get your Demo now: https://smart-eye.io Podcast Nostalgia How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/ How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/ What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/ Easy Medical Device support - info@easymedicaldevice.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. ➕ In today's

Andy Moye is a seasoned commercial leader and corporate development executive who has worked across the molecular diagnostics, biotechnology and life sciences industries. He is currently Chief Executive Officer at Paige and previously served as Chief Commercial Officer, where he led the company's clinical sales and commercial strategy, including the U.S. launch of Paige Prostate, the first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies. Previously, Moye served as Head of Commercial Operations in North America and Latin America for the Digital and Computational Pathology division of Philips, delivering significant growth in both markets for the emerging business. Moye has also served in executive roles at leading healthcare companies, including Ontada, a division of McKesson, Caris Life Sciences, and WaferGen Bio-systems, now part of Takara Bio. Prior to joining the industry, Moye served as a Lieutenant and flight officer in the U.S. Navy, completing missions in Bosnia, Kosovo, Iraq, Europe, and South America. He received a Ph.D. in health economics from Walden University, MBA from the University of Florida and B.S. in physiology from the University of Arizona.   

EU Manual on Borderline and classification for Medical Devices Update - New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf Q&A on Annex XVI Products - Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf Italy: Custom-made medical device registration - Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352 Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0 Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/ Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/   FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland UK The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase CH Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024:  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf Conferences Which conferences to focus on?  - I will be going to them so join me. MEDXD: Digitalisation of Medtech: https://medtechx.digital/ Afrisummit in Egypt:  https://www.pharmaregafrisummit.com/ Medica: https://www.medica-tradefair.com/ Team-PRRC: https://www.team-prrc.eu/ Training Trainings for you - Self-paced Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/ US US FDA - De Novo Request - Electronic Submission template: https://www.fda.gov/media/172450/download Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content Webinar US FDA  - Breakthrough devices program update - November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023 Digital Health FAQ - Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs ISO 10993-1:2018 versus FDA - FDA is adding its touch: https://www.fda.gov/media/142959/download Best practice for selecting a Predicate device for your 510K - Method provided. https://www.fda.gov/media/171838/download Saudi Arabia SFDA Significant changes guidance - Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf Malaysia Malaysia: Workshop preparation of documents for Submission -  October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html   Turkey Mutual Recognition of Authorized rep and NB in Turkey - Good clarification:  https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242Japan Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf India India: List of registered medical device testing laboratory - under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE= Podcast Podcast Nostalgia - Do you remember? Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/ and 250: part 2: https://podcast.easymedicaldevice.com/250-2/ Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/ QMS How Easy Medical Device can help you -easymedicaldevice.com We can also help you implement our eQMS - Smarteye: https://smart-eye.io

This episode's Community Champion Sponsor is Catalyst. To virtually tour Catalyst and claim your space on campus, or host an upcoming event: CLICK HERE---Episode Overview: During this episode, we spend time with Dr. Agim Beshiri, Chief Medical Officer of Nutromics, an international leader pioneering continuous diagnostic monitoring to transform personalized care. Bringing over 20 years of clinical and industry expertise, Agim is driven to advance patient-centric precision medicine. While together, Agim shares how Nutromics utilizes synthetic DNA sensors for real-time, first-order molecular recognition. Additionally, Agim unpacks the future of scaling personalized treatment through continuous multiplexed monitoring. We also discuss reinventing antiquated blood testing methodologies and paradigm shifts enabling preventative intervention. Join us as Agim outlines a vision for mimicking implanted diagnostic tools across diverse disease states and to gain inspiration from his dedication to elevating global standards of care through innovative diagnostics. Let's go! Episode Highlights:Agim brings deep medical affairs experience to transform diagnostic testingHow Nutromics uses synthetic DNA sensors for continuous, multiplexed monitoringWays in which Nutromics enables real-time precision dosing adjustments and early interventionsAgim envisions scaling continuous diagnostics across diverse disease statesHow Agim exemplifies commitment to profoundly advancing personalized medicine About our Guest: Agim Beshiri, M.D., is the Chief Medical Officer (CMO) at MedTech startup Nutromics. His passion is in elevating the standard of care for all patients. With over 20 years' experience in the IVD field both in the clinical setting and industry. Dr Beshiri developed methods and collaborations that enabled patient-centric application of diagnostics addressing underserved patients in disease states from cardiology to oncology.A leading industry expert in developing a medical affairs organization and driving medical research and education. With a broad background in internal medicine, hematology, general cardiology, and laboratory medicine, Dr Beshiri initiated and collaborated on research programs resulting in over 800 research collaborations and over 1000 publications.Prior to Nutromics, Dr Beshiri was Senior Medical Director at Abbott Laboratories where he developed supporting their Diagnostics organization for over 16 years. His clinical experience includes the Brooke Army Medical Center in Texas, the 452nd Combat Support Hospital in Wisconsin and Aurora/Advocate Clinical Laboratories in Wisconsin and Illinois, and South-eastern Europe.Dr. Beshiri is a member of several organizations, including the American Medical Association, American Heart Association, European Society of Cardiology, International Society for Laboratory Hematology, European Hematology Association, American Society of Hematology, and American Society of Clinical Oncology. He has also served on guideline subcommittees for the Clinical and Laboratory Standards Institute.Links Supporting This Episode:Nutromics Website: CLICK HEREDr. Agim Beshiri LinkedIn page: CLICK HERENutromics Twitter page: CLICK HERE Mike Biselli LinkedIn page:

AI is the new tool of choice for battling cancer, and Andy Moye's company is at the forefront on a mission to advance cancer detection and patient care and treatment by using cutting-edge artificial intelligence.They are revolutionizing and accelerating the way we conquer this universal enemy.Andy is CEO and Board Member at Paige AI, which is the only company that FDA approved to use AI in diagnosing cancer pathology.This includes the U.S. launch of Paige Prostate Detect, the first and only AI-based pathology product to receive FDA marketing authorization for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies.His involvement in pathology began around 2005 and he's been at the forefront of the molecular diagnostics, biotechnology, and life sciences industries for nearly two decades, focusing on pathology, oncology, genomics, and precision medicine.Before that, he served in the Navy for eight years flying P-3C aircraft.LinkedIn Profile https://www.linkedin.com/in/andymoye/Company Link: https://paige.ai/What You'll Discover in this Episode:AI's impact on the healthcare industry.The two sides of AI that will have the biggest impact in the next three to five years.Rampant physician burnout - How AI is addressing it.What company leaders should be asking their health benefit providers.The moment he realized he wanted to lead in healthcare.The one skill that's contributed most to his success.A strategy that motivates your team.Why an AI company prioritizes people first.Are you trying to get your team to like you? Don't!What he learned from having one-on-one's with 100 employees.-----Connect with the Host, #1 bestselling author Ben FanningSpeaking and Training inquiresSubscribe to my Youtube channelLinkedInInstagramTwitter

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.

Six Sigma is a popular way to measure quality. Sigma metrics have been adapted for the clinical laboratory by incorporating observed accuracy, precision and total error allowed (TEa). In vitro diagnostic (IVD) manufacturers have used Six Sigma to assess the quality of their assays using a small number of well-controlled systems to generate the data. QuidelOrtho has developed a novel approach to assess laboratory Sigma metrics for a broad range of assays using data from over 1,300 Vitros® instruments used in clinical labs.  In this podcast, Johanna Miller, data scientist at QuidelOrtho, discusses the value of using real-world data to perform Sigma metric studies and how a lab can use this information.    About Our Speaker:  Johanna Miller holds a bachelor's degree in biomedical engineering from the University of Rochester and a master's in product development and data science from the Rochester Institute of Technology. She spent 10 years developing expertise on Vitros systems and the data it generates, while working in product development. Currently, she focuses on developing new and interesting methods to use data at QuidelOrtho - specifically to bring insights directly to labs using Six Sigma quality scores. 

On this week's episode, Rich Thayer and Mickey Urdea are delving into diagnostics regulations with David Kern, detailing the myriad changes in the regulatory landscape since the pandemic in the United States as well as the implications of the new IVDR regulations in Europe. There are few people who can make regulatory as downright enjoyable as Dave Kern; please enjoy his delightful interview. David Kern is the founder of K2 Regulatory Consulting. With 30+ years of experience in the IVD medical device industry, he has held positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs at Illumina, where he built a global regulatory organization, with offices in China, Australia, and the UK. Dave has a B.S degree in Biochemistry from San Francisco State University, an MBA from San Jose State University, and holds a RAC from the Regulatory Affairs Professional Society (RAPS). He is also an instructor at UC Santa Cruz Extension.

Track Listing:1 Nielsen: Symphony No. 1 in G Minor, Op. 7: / I. Allegro orgoglioso 09:202 II. Andante 07:473 III. Allegro comodo 07:494 IV. Allegro con fuoco 08:58 5 Symphony No. 2, Op. 16 The Four Temperaments / I. Allegro collerico 10:066 II. Allegro comodo e flemmatico 04:567 III. Andante malincolico 12:568 IV. Allegro sanguineo 07:02 9 Symphony No. 3, Op. 27 Espansiva / I. Allegro espansivo 11:0910 II. Andante pastorale 10:3811 III. Allegretto un poco 06:4312 IV. Finale. Allegro 10:52 13 Symphony No. 4, Op. 29 The Inextinguishable / I. Allegro 12:2114 II. Poco allegretto 04:3215 III. Poco adagio quasi andante 10:4716 IV. Allegro 08:51 17 Symphony No. 5, Op. 50: Ia. Tempo giusto 10:2918 Ib. Adagio 08:5219 IIa. Allegro 06:1420 IIb. Presto 02:5821 IIc. Andante poco tranquillo 04:2022 IId. Allegro 02:5623 Symphony No. 6 Sinfonia Semplice / I. Tempo giusto 14:2724 II. Humoreske 04:1125 III. Proposta seria 05:2726 IVa. Allegro – Tema. Allegretto un poco 00:5827 IVb. Var. 1 00:3228 IVc. Var. 2. Allegretto quasi andantino 00:2829 IVd. Var. 3. Più vivo – Var. 4. – Var. 5. Brioso 02:1730 IVe. Var. 6. Tempo di Valse – Var. 7 02:1131 IVf. Var. 8. Molto adagio 03:0232 IVg. Var. 9. Tempo di tema 00:2833 IVh. Fanfare 01:44Help support our show by purchasing this album  at:Downloads (classicalmusicdiscoveries.store) Classical Music Discoveries is sponsored by Uber and Apple Classical. @CMDHedgecock#ClassicalMusicDiscoveries #KeepClassicalMusicAlive#CMDGrandOperaCompanyofVenice #CMDParisPhilharmonicinOrléans#CMDGermanOperaCompanyofBerlin#CMDGrandOperaCompanyofBarcelonaSpain#ClassicalMusicLivesOn#Uber#AppleClassical Please consider supporting our show, thank you!Donate (classicalmusicdiscoveries.store) staff@classicalmusicdiscoveries.com This album is broadcasted with the permission of Crossover Media Music Promotion (Zachary Swanson and Amanda Bloom).

IVD is in the building and spilling the tea on life as a female rapper, friendship and dating. AP and Maz talk stag do's and your men liking baddie pics on the gram. Send the girls your juicy voice notes on 07594 520 584. PRESSED is a BBC Studios and Unheard Network production. Exec Producer: Pete Strauss Producer: Pilar Nalwimba Editor: Faith Howley Production Coordinator: Sarah Nicholls