Podcasts about sscp

The SSCP is a globally recognized certification that validates technical skills in implementing, monitoring, and managing IT infrastructure using security best practices, policies, and procedures, which are essential for cybersecurity professionals.

Reunited and it feels so good! The Super Scary Crew talks about the revamp of the SSCP and of course Keep it Spooky --- Support this podcast: https://podcasters.spotify.com/pod/show/superscarypod666999/support

Ready to launch your career in cybersecurity? In this episode of the InfosecTrain podcast, we explore how the SSCP (Systems Security Certified Practitioner) certification can be your gateway to success in the cybersecurity field. Our experts break down the key benefits of earning the SSCP, what the certification covers, and how it can help you stand out in a competitive job market. Whether you're new to cybersecurity or looking to advance your skills, this episode offers actionable insights on how to prepare for the SSCP exam, the career opportunities it opens up, and why it's a must-have for aspiring security professionals. Tune in to discover how the SSCP certification can accelerate your cybersecurity career and set you on the path to success!

Durante este sexenio se han decomisado 8 mil 306 kilos de fentanilio: SedenaIMSS aprueba sustitución de elevadores Rusia inflinge en el ejercito de Ucrania   Más información en nuestro podcast

In this episode we discuss the Boeing whistleblower John Barnett, who "killed himself" for unknown reasons in the middle of his lawsuit against the company. Don't worry, we'll put this "conspiracy theory" to "rest" in this highly anticipated installment of SSCP.https://twitter.com/statsponconpodstatsponconpod@protonmail.comIntro/outro: https://slowfreq.bandcamp.com/album/omoidmed

What is Corner Bakery doing to right its ship? This week's episode of the Restaurant Business podcast A Deeper Dive features Chris Dharod, the CEO of Corner Bakery. Dharod is with SSCP Management, a franchisee of Applebee's and Sonic and owner of Cici's Pizza and Roy's. The company bought Corner Bakery out of bankruptcy last year. We had him on the podcast to talk about Corner Bakery and chat about the way in which the acquisition was made. SSCP acquired the brand by buying the debt on the secondary market and then using that to take over the company out of bankruptcy, a process some folks call loan to own. Dharod talks about that process, its risks and what SSCP looks for in its investments, as well as how it turns them around, which it has done with Cici's. Corner Bakery is a particularly difficult process. The brand was owned by the same owner as Boston Market and was having many of the same problems. It didn't pay many of its bills and was burdened by lawsuits and serious issues. We talk about what the brand is doing to fix all that, what kind of people it brought in and what kind of sales the brand is generating now. We're talking Corner Bakery on A Deeper Dive so please check it out.

#CiroEnImagen Pese a la confirmación de 9 muertos en un enfrentamiento entre policías de Cuernavaca y criminales, la SSCP reportó 3 muertes en cifras preliminares. Hoy se conoció más información de la balacera: See omnystudio.com/listener for privacy information.

#ENVIVO Pese a la confirmación de 9 muertos en un enfrentamiento entre policías de Cuernavaca y criminales, la SSCP solo reportó 3 muertes en sus cifras preliminares. Y habitantes agredieron a policías municipales durante una protesta por el cierre de bares clandestinos en #Puebla: See omnystudio.com/listener for privacy information.

Join us to delve into the pivotal interplay between artificial intelligence and cybersecurity. Join us as we unravel the ways AI is transforming threat detection, intrusion prevention, and incident response. We'll explore real-world applications, benefits, challenges, and the ethical dimensions of AI in cybersecurity. Be part of the conversation to stay informed about the latest trends and essential insights for navigating this evolving landscape effectively. Presenters: Amy McLaughlin, MS, MA, CETL, CISM, CHPS, CDPSE, CISSP, CoSN Cybersecurity Project Director,Executive Director, Technical and Solutions Architecture Oregon State University (OR) Bryan Ruzenski, Director of External Technology Services, Chester County Intermediate Unit (PA) Corey O'Connor, CETL, Director of Technology , Montgomery County Educational Service Center (OH) Thomas Molina, PMP, CISSP, SSCP, CTO, Corpus Christi Independent School District (TX) Jennifer Clouser, CETL,  Executive Director, Department of Technology, Auburn School District #408 (WA) In our professional advancement webinars, education technology experts from across the country and worldwide present their specialties. During each interactive session, experts engage in dialogue to address the challenges and opportunities facing educators. Webinars are FREE for members and $59 for non-members. Partner webinars are free for all. For a complete listing of all CoSN's webinars, please visit:⁠ ⁠⁠⁠https://www.cosn.org/education-events/webinars/⁠⁠⁠⁠ Be sure to follow us on Twitter ⁠⁠⁠⁠@CoSN⁠⁠⁠⁠ and ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠ to stay updated on CoSN events!

El presidente López Obrador anunció que Luisa María Alcalde reemplazará a Adán Augusto López como titular de la Secretaría de Gobernación; además, la SSCP y el Consejo Mundial de Boxeo se unen contra las adicciones en México. Hosted on Acast. See acast.com/privacy for more information.

El presidente López Obrador anunció que Luisa María Alcalde reemplazará a Adán Augusto López como titular de la Secretaría de Gobernación; además, la SSCP y el Consejo Mundial de Boxeo se unen contra las adicciones en México. Hosted on Acast. See acast.com/privacy for more information.

AMLO anunció que vendió el avión presidencial al gobierno de Tayikistán por mil 658 millones de pesos; además, Starship, el cohete de Elon Musk y SpaceX, explotó en su vuelo de prueba, y la SCJN fijó para 2024 el regreso de la Guardia Nacional a la SSCP. Hosted on Acast. See acast.com/privacy for more information.

AMLO anunció que vendió el avión presidencial al gobierno de Tayikistán por mil 658 millones de pesos; además, Starship, el cohete de Elon Musk y SpaceX, explotó en su vuelo de prueba, y la SCJN fijó para 2024 el regreso de la Guardia Nacional a la SSCP. Hosted on Acast. See acast.com/privacy for more information.

Chris Dharod, President, SSCP which owns locations of  CiCi's, Applebee's, Sonic, and Roy's talks to KRLD's David Johnson

Welcome back visitor! Today will be easy as it requires no hiking. Just enjoying a nice, relaxing ride on a dragon turtle, who has kindly offered to take us to the South China Sea. We'll be looking for the jiaoren, the Chinese mermaids who cry pearls instead of tears. And we may just run in to an unexpected surprise on the way! Sources Cited: Alan Rankin Last Modified Date: August 26 & Alan Rankin Date: August 26, 2022. What is a dragon turtle? All Things Nature. Available at: https://www.allthingsnature.org/what-is-a-dragon-turtle.htm [Accessed September 6, 2022]. Creative, J.L., Jiaoren. Westport Winery Garden Resort - Jiaoren. Available at: https://www.westportwinery.com/oceans-daughter-distillery/spirit-list/duckleberry-grunt.html [Accessed September 6, 2022]Hansen, C., 2014. Zhuangzi. Stanford Encyclopedia of Philosophy. Available at: https://plato.stanford.edu/entries/zhuangzi/ [Accessed September 6, 2022]. jamespederson5, 2021. Mythic creature of the day: Jiaoren. Mythology Worlds. Available at: https://www.mythologyworlds.com/post/mythic-creature-of-the-day-jiaoren [Accessed September 6, 2022].  Peng symbolizes great aspiration, indomitable will-SSCP. (n.d.). Retrieved September 6, 2022, from http://www.csstoday.com/Item/5510.aspx

El presidente Andrés Manuel López Obrado Anunció que emitirá un acuerdo presidencial para que la GN pase a la SEDENA y ya no a SSPC.

El 25 por ciento del país está bajo alerta de violencia de género, por lo que la SSCP no baja los brazos para terminar esta crisis; además, Europa dejará de exigir el uso de cubrebocas en aviones y aeropuertos. Hosted on Acast. See acast.com/privacy for more information.

El 25 por ciento del país está bajo alerta de violencia de género, por lo que la SSCP no baja los brazos para terminar esta crisis; además, Europa dejará de exigir el uso de cubrebocas en aviones y aeropuertos. See acast.com/privacy for privacy and opt-out information.

HOT TOPIC Joint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRA MDCG 2019-9 Rev 1 – SSCP update https://ec.europa.eu/health/document/download/5f082b2f-8d51-495c-9ab9-985a9f39ece4_en?filename=md_mdcg_2019_9_sscp_en.pdf EU Handover of Experts Panels to EMA: https://ec.europa.eu/health/latest-updates/handover-experts-panels-secretariat-2022-03-02_en SNITEM and BVMED ask for 2 additional years for the MDR transition period: https://www.bvmed.de/de/bvmed/presse/pressemeldungen/bvmed-und-snitem-starten-deutsch-franzoesische-initiative-zur-mdr-wir-muessen-jetzt-handeln Swissmedic: Database for registering Economic Operators and Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html AEMPS. Prior operating license for medical devices: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/nueva-instruccion-de-la-aemps-sobre-el-procedimiento-de-licencia-previa-de-funcionamiento-de-instalaciones-de-productos-sanitarios/ US MEDSUN: https://www.fda.gov/media/156691/download China: Guidelines for registration and review of Artificial Intelligence Medical Devices: https://www.cmde.org.cn/CL0112/25219.html Egypt: Guideline for labeling data on medical supplies: https://edaegypt.gov.eg/media/q23cqi5w/minimum-label-req-english-version_nancy-fateen.pdf Events Team PRRC Webinar April 12th, Sanctions if non-compliance to the regulation? https://www.linkedin.com/posts/team-prrc_mdr-ivdr-prrc-activity-6914642561617833985-5Moe Medtech Forum 3-5 May 2022: https://www.themedtechforum.eu/ Green Belt Certification programFrench April 18th until April 22nd: https://school.easymedicaldevice.com/course/gbfr3/ English April 25th, until April 29th: https://school.easymedicaldevice.com/course/gb18/ Notified Bodies SIQ Slovenia Institute of Quality and Metrology: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=316903&version_no=12 EMD Episode 170 – Why do we need the Common Specification for Class D IVDR [Andreas Stange] https://podcast.easymedicaldevice.com/170/ Episode 171 – What lesson did we learn doing Clinical Evaluations? [Cesare Magri] https://podcast.easymedicaldevice.com/171/ Episode 172 – How to sell Medical Devices online in the EU and US? [Michael Wetherington] https://podcast.easymedicaldevice.com/172/ Episode 173 – What are the surprises during the MDR & IVDR transition [Erik Vollebregt] https://podcast.easymedicaldevice.com/173/

Com a chegada da certificação Entry Level da (ISC)2, como fica a certificação SSCP que antes era considerada a certificação inicial. Trabalhe como especialista em Segurança da Informação no Brasil ou em qualquer outro país. Assine minha newsletter em https://sobiecki.net/newsletter/ Visite: https://www.sobiecki.net Meus Links: https://linktr.ee/fabiosobiecki

This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions. On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to our panel of former notified body leaders and industry experts. Five months have passed and our educated guess is you have even more challenges and questions to bring to the table. If you do, our team is ready for them. While many of you in the device industry have achieved certification for some or all of your products, we know it can be just as big of a challenge to keep up with all the new requirements for post-market reporting and documentation updates. For IVD manufactures, hang on to your hats because as your device colleagues can attest, you have a difficult road ahead and the post-certification phase will not provide much relief. As always, our RQM+ experts are thrilled to utilize our Live! show platform as a way to knowledge-share across the industry. Please bring your toughest questions and join the discussion because we're here to help! Panelists: Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation Carlos Galamba, MSc - Vice President of IVD Intelligence & Innovation Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services Jonathan Gimbel, Ph.D. – Executive Director, Technical Leadership, Clinical & Post-Market Practice Questions: 3:29 -- Summarization of new requirements of the post-market phase (if watching video, includes with graphic) 5:40 -- In preparation for MDR, how long should updating everything actually take and how long is too long? 8:04 -- In preparation for IVDR, how long should updating everything actually take and how long is too long? 8:59 -- Is there an ETA for the MDCG guidance template for PSURs? 10:04 -- Do you believe that EUDAMED when it actually goes live will be a good resource for post-market data in the same vein as MOD when doing updates for the CER and PMCF? 13:44 -- What experience have you seen from the notified bodies for accessing the readability of the SSCPs? 19:09 -- If three months is the suggested timeframe for having most recent data, then how is the RQM+ PMCF completion of 29-32 weeks falling in this schedule? What are the chances the notified body would comment that the data doesn't have value? 21:05 -- What kind of data specifically has to be less than six months old? 24:03 -- Have you had feedback on if deviating from IFU language is acceptable for the SSCP to improve readability to that 14-year-old level? 27:14 -- Our regular moderator Lisa forgets to unmute herself for the first time in the history of RQM+ Live! She had a good run. ;-) 27:24 -- Should MDCG be referenced in the GSPR checklist or rather in the body of the Annex II technical documentation? 29:18 -- Our company believes that resource levels should go down after certification. How do I convey that maintenance in PMS will be intensive? (answered by function) 37:18 -- In September of 2021, BSI did a webinar about PSURs and PMS reporting and stated that data outside the 90-day window was not acceptable. Has that changed? 38:22 -- What is an acceptable frequency for the PMCF literature search activity for different classes of devices? 39:29 -- How much harder is a design change MDR than it was under MDD? 41:17 -- Is a PMCF plan required for Class Is devices? 42:36 -- What do you recommend IVD manufacturers be thinking about or implementing now to be ready for the sustaining phase? --- Send in a voice message: https://anchor.fm/deviceadvice/message

APMG International presents our popular Level Up panel Q&A show. This episode is about how to Level Up your Cyber Resilience with the Host: Nick Houlton and Question Master: Suchitra Jacob. Panelists; Melanie Oldham, Anna Collard, Tim Harwood, Etienne Shardlow, and Nigel Mercer. An opportunity to have your real-life questions answered, driving the panel discussion before moving onto the focus topic: Combatting online fraud with Melanie Oldham.

In this special “Tech Spotlight” episode of Automation Chat, host Theresa Houck, Executive Editor of The Journal From Rockwell Automation and Our PartnerNetwork magazine, chats with Kevin Reed, Technical Support & Applications Engineer at LinMot USA, a Rockwell Automation Technology Partner. They talk about the company's intelligent SSCP stainless steel linear motors, designed for applications with high demands on materials and protection class, such as pharmaceutical and food & beverage. They discuss the motors' composition and how they operate; guided options; assembly configurations; and applications for these corrosion-resistant motors. Access more resources here: LinMot USA Inc. Stainless Steel Linear Motors SSCP Stainless Steel Linear Modules SM01 If you like “Automation Chat,” please leave us a 5-star rating and subscribe. Video of this podcast chat is available on our YouTube channel at https://youtu.be/51DKUUCMg-4. The Journal From Rockwell Automation and Our PartnerNetwork magazine online: http://rok.auto/thejournal.

On WHBC's “Live And Local”, Jordan Miller speaks with restaurant industry expert Chris Dharod, President of SSCP, to discuss possible “no vaccination, no service” demands at restaurants.

This is the audio-only version of RQM+ Live! #36, originally recorded June 3, 2021. We're back for part two! With so many questions we couldn't address during our April 22, 2021 show on this topic (available on demand), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help, so here's a second chance to learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day. "Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more: What types of clinical evidence gaps are notified bodies citing? What are some solutions to enable keeping your devices on the market? What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified body acceptance? How do you leverage your PMCF plan as a mitigation for clinical data weakness? How do you make all of the documentation sing together - CER, PMCF plan, SSCP, Risk file, labeling - providing a cohesive clinical evidence story to the notified body that they can feel good about approving? Our panel includes Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just months out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day! Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services Sally Sennitt, MBBS, FRCA - Medical Director - About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com. --- Send in a voice message: https://anchor.fm/devicelove/message

This is the audio-only version of RQM+ Live! #33, originally recorded April 22, 2021. "Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more: What types of clinical evidence gaps are notified bodies citing? What are some solutions to enable keeping your devices on the market? What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified body acceptance? How do you leverage your PMCF plan as a mitigation for clinical data weakness? How do you make all of the documentation sing together - CER, PMCF plan, SSCP, Risk file, labeling - providing a cohesive clinical evidence story to the notified body that they can feel good about approving? Our panel include Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just weeks out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day! Panelists: Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services Sally Sennitt, MBBS, FRCA - Medical Director - About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com. --- Send in a voice message: https://anchor.fm/devicelove/message

This is the audio-only version of DEVICE LOVE Live! #29, originally recorded February 25, 2021. There has been plenty of discussion regarding what "good enough" means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “grandfathering” for legacy devices, which means that in some cases significant technical documentation remediation may be required (with similarly significant associated costs). There is also a more explicit emphasis on PMS, PMCF, and continual updates of related documentation. At the same time, the MDR requires much greater transparency of information, as evidenced by requirements such as SSCP, and this will require public disclosure of evidence that manufacturers may previously have considered confidential. As a result, manufactures may choose to "test the waters" first by submitting technical documentation that pushes the boundaries of what may be perceived to be acceptable. However, does this really save manufacturers money in the long run? You may be surprised to learn from our former notified body leaders and regulatory experts how much this strategy really costs you. Please join us for this eye-opening discussion! Amie Smirthwaite, Ph.D. - Head of Clinical Regulatory Affairs, RQM+ Jaishankar (Jai) Kutty, Ph.D. - Vice President of Clinical Services, RQM+ Ron Sills - Senior Principal Specialist, RQM+ - About RQM+ RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com. --- Send in a voice message: https://anchor.fm/devicelove/message

This is the audio-only version of DEVICE LOVE Live! #22, originally recorded 5 November 2020. The Summary of Safety and Clinical Performance or "SSCP" is required by EU MDR for Class III and implantable devices. The SSCP must be reviewed every year, for the lifetime of the device, and is a public facing document. The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The MDCG 2019-9 guidance calls for significant detail that device manufacturers would prefer to keep confidential. As a result, creating an SSCP that meets the regulatory requirements and is acceptable to the Marketing and Legal teams is incredibly challenging. Further complications are having an SSCP that's suitable for patient review, providing multiple translations, and updating this long and comprehensive document annually. R&Q has submitted multiple SSCPs and received notified body feedback. Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies. Ibim Tariah, Ph.D. – VP of EU MDR and IVDR Consulting Services, R&Q (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI) Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI) Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team, R&Q Moderator: Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com. The and means more. --- Send in a voice message: https://anchor.fm/devicelove/message

Gaylynn Fassler, MS, SSCP is here to talk about her journey into the industry and will give a sneak peek into her upcoming talk at the Triangle InfoSeCon, hosted by ISSA Raleigh Chapter. Bring your questions! This series was created by Renee Small & ☁️ Christophe Foulon ☁️ to share stories of how the most recent cybersecurity professionals are breaking into the industry. We hope this helps you in your quest to break into cybersecurity as well. Our special editions are us talking to experts in their fields and cyber gurus who share their experiences of helping others break in. #breakingintocybersecurity #securitypeeps #cybersecurity #informationsecurity #cybersecurityawarenessmonth #day27of31 _________________________________________ About the hosts: Renee Small is the CEO of Cyber Human Capital, one of the leading human resources business partners in the field of cybersecurity, and author of the Amazon #1 best-selling book, Magnetic Hiring: Your Company's Secret Weapon to Attracting Top Cyber Security Talent. She is committed to helping leaders close the cybersecurity talent gap by hiring from within and helping more people get into the lucrative cybersecurity profession. https://www.linkedin.com/in/reneebrownsmall/ Download a free copy of her book at: magnetichiring.com/book Christophe Foulon focuses on helping to secure people and process with a solid understanding of the technology involved. He has over 10 years as an experienced Information Security Manager and Cybersecurity Strategist with a passion for customer service, process improvement, and information security. He has significant experience in optimizing the use of technology while balancing the implications to people, process, and information security by using a consultative approach. https://www.linkedin.com/in/christophefoulon/ https://cpfcoaching.wordpress.com Podcast Links: https://anchor.fm/breakingintocybersecurity https://www.youtube.com/playlist?list=PL2Td9LH7jZlAW9R5xMdwRPZH28Zi7pq3R --- Support this podcast: https://anchor.fm/breakingintocybersecurity/support

This is the audio-only version of DEVICE LOVE Live! #17, originally recorded September 10, 2020. The Periodic Safety Update Report or "PSUR" is required by EU MDR for each Class IIa, IIb, and III device, and IVDR for Class C and D IVD's. It must be updated it at least every two years, for the lifetime of the device. The PSUR provides a comprehensive risk-benefit analysis with periodic updates, pulling data from multiple sources that may not be accustomed to interacting with each other in an efficient way (Risk Management, CER's, PMCF and PMS/Complaints). The requirements in the regulation are new and seem to overlap with existing reports. We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive. Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies? Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies. Here's the panel: Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team Celeste Maksim, Ph.D. – Principal Consultant, R&Q Brian Hockett – Project Engineer, R&Q Moderator: Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com. The and means more. --- Send in a voice message: https://anchor.fm/devicelove/message