Podcasts about rqm

  • 16PODCASTS
  • 137EPISODES
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  • 1EPISODE EVERY OTHER WEEK
  • May 1, 2025LATEST

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Best podcasts about rqm

Latest podcast episodes about rqm

Balad'eau
Et si la mer bouclait la boucle? On jase d'économie circulaire bleue

Balad'eau

Play Episode Listen Later May 1, 2025 90:43


Dans cet épisode spécial, on vous propose la version intégrale d'un webinaire consacré à un thème encore peu connu, mais essentiel : l'économie bleue circulaire. Que se passe-t-il quand on applique les principes de l'économie circulaire aux activités maritimes, côtières et portuaires? Quels projets concrets émergent au Québec, en France et ailleurs? Une conversation croisée entre chercheurs, industriels et acteurs du terrain, pour comprendre les défis, les leviers, et les solutions possibles.

Device Advice by RQM+
Live! #87 – Built for Her: Funding, fixing, and fueling the next era of MedTech

Device Advice by RQM+

Play Episode Listen Later Apr 8, 2025 61:09


This panel was recorded 20 March 2025.⁠⁠⁠ Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the⁠ Knowledge Center⁠ at RQMplus.com.Women's health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.Why listen:Unlock Market Opportunities – Women's health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.Discussion topics:The Business Case for Women's Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.Scaling Women's Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.Who should listen:MedTech professionals driving innovation in women's healthRegulatory and quality leaders navigating complex approval pathwaysClinical trial specialists improving diversity and data accuracyInvestors and strategists seeking insights into funding and market growthR&D and product development teams designing women's health solutionsHealthcare policymakers and advocates shaping the future of women's health innovationPanelists and moderator:Marissa Fayer – CEO, Her Health Equity & DeepLook MedicalMegan Callanan – US & Global Regulatory Lead, Natural CyclesStephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos BioscienceAlexia Haralambous – Senior Principal, RQM+Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)Chapters:00:00 Introduction to Women's Health in MedTech10:09 The Surge in Women's Health Innovation20:08 Regulatory Challenges in Women's Health29:52 The Business Case for Women's Health Innovation33:54 Bridging the Gender Gap in Clinical Trials37:02 Enhancing Diversity in Clinical Trial Recruitment40:08 Understanding Regulatory Misconceptions in Women's Health44:09 Strategic Partnerships for Market Access56:03 Future Directions for Women's Health Innovation--

Device Advice by RQM+
Breast Cancer Panel, Part 1: Diagnosis and Personal Journeys

Device Advice by RQM+

Play Episode Listen Later Apr 4, 2025 18:57


In this powerful first part of a three-part series, RQM+ employees bravely share their personal journeys from the moment of diagnosis through the emotional and physical challenges they faced. Their stories offer inspiration, resilience, and valuable insights into the realities of breast cancer diagnosis.--

Device Advice by RQM+
Weekly Watch #51 (AI-Generated, Subscribe On LinkedIn)

Device Advice by RQM+

Play Episode Listen Later Apr 2, 2025 22:32


This is an experiment and AI-generated audio version of edition #51 of our weekly LinkedIn newsletter, the ⁠⁠⁠RQM+ Weekly Watch⁠⁠⁠.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.A new edition of the RQM+ Weekly Watch is published on LinkedIn every Tuesday.--

Device Advice by RQM+
Weekly Watch #48 (AI-Generated, Subscribe On LinkedIn)

Device Advice by RQM+

Play Episode Listen Later Mar 11, 2025 29:43


This is an experiment and AI-generated audio version of edition #48 of our weekly LinkedIn newsletter, the ⁠⁠RQM+ Weekly Watch⁠⁠.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter ⁠⁠here⁠⁠. A new edition is published to LinkedIn every Tuesday.--

Device Advice by RQM+
Celebrating the Women Who Inspire Us

Device Advice by RQM+

Play Episode Listen Later Mar 10, 2025 13:13


In celebration of International Women's Day , we asked our team to talk about the most influential women in their lives.Their stories had us tearing up, tbh.

Device Advice by RQM+
Weekly Watch #47 (AI-Generated, Subscribe On LinkedIn)

Device Advice by RQM+

Play Episode Listen Later Mar 6, 2025 17:11


This is an experiment and AI-generated audio version of edition #47 of our weekly LinkedIn newsletter, the ⁠RQM+ Weekly Watch⁠.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter ⁠here⁠. A new edition is published to LinkedIn every Tuesday.--

Device Advice by RQM+
Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD

Device Advice by RQM+

Play Episode Listen Later Feb 12, 2025 73:28


⁠This panel was recorded 30 January 2025.⁠⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.Join part two of our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.Our panel of industry experts will provide clear, implementable guidance on:Practical strategies for meeting EU MDR and US FDA cybersecurity requirements - with real-world examples and documentation approachesEssential security considerations for medical devices, IVDs and SaMD developmentHow to integrate cybersecurity requirements into your quality management system from the startStandards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectivesStrategic planning for maintaining security throughout your product lifecycleCommon pitfalls to avoid in cybersecurity implementation and regulatory submissionsThe role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory complianceWho Should Attend:This session is essential for medical device manufacturers, software developers, quality professionals, and regulatory teams working with connected devices or SaMD. Whether you're bringing your first connected device to market or optimizing your current cybersecurity approach, you'll gain practical insights for ensuring both compliance and security.Panelists:Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation, RQM+Mirko Raner – Cybersecurity Consultant, RQM+Hrishikesh Gadagkar – Senior Principal, RQM+Moderator:Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+Register now to gain practical insights that will help you navigate the evolving cybersecurity landscape with confidence, backed by RQM+'s extensive experience in medical device regulatory compliance and software validation.Part one is available on demand here.Chapters00:00 Introduction to Medical Device Cybersecurity03:21 Navigating FDA Regulations and Cybersecurity11:38 Effective Documentation Frameworks for Cybersecurity15:47 Understanding Medical Device Data Systems (MDDS)24:12 Cybersecurity Challenges for In Vitro Diagnostic (IVD) Devices27:02 Addressing Cybersecurity in Interconnected Devices32:41 Risk Assessment and Cybersecurity Documentation37:12 Understanding FDA Regulations for Medical Devices40:54 Cybersecurity Considerations in Medical Devices42:00 Assessing Cybersecurity Threats and Vulnerabilities49:02 The Role of Risk Analysis in Cybersecurity Documentation56:46 Integrating Cybersecurity and Safety Risk Assessments01:09:53 Future-Proofing Against Cyber Threats--

Device Advice by RQM+
Live! #85 – Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD

Device Advice by RQM+

Play Episode Listen Later Dec 19, 2024 63:14


⁠This panel was recorded 12 December 2024. ⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

Device Advice by RQM+
Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework

Device Advice by RQM+

Play Episode Listen Later Dec 5, 2024 57:42


This presentation panel was recorded 21 November 2024. Please join us live for future shows for the chance to participate in the chat and ask your own questions! You can sign up for these events and see more free thought leadership content in the ⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

Device Advice by RQM+
Chris Parr, Principal Consultant | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Nov 14, 2024 13:23


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.

Device Advice by RQM+
Carrie Schneider, Principal Consultant | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Nov 7, 2024 14:35


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. An 18-yr old McDonald's manager at Purdue University's campus restaurant just so happened to find her

Device Advice by RQM+
What makes a successful regulatory submission from a clinical trial perspective for IVDs? – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

Play Episode Listen Later Nov 4, 2024 9:58


*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.*

Device Advice by RQM+
Holly Cotter, Senior Consultant | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Oct 28, 2024 14:53


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.

Device Advice by RQM+
What makes a successful regulatory submission from a clinical trial perspective? (Part 3/3) – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

Play Episode Listen Later Oct 22, 2024 9:57


*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 the final installment of this three-part series, Jaishankar Kutty, Ph.D. concludes the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Critical study design elements that can make or break a regulatory submission Navigating global clinical studies and patient population requirements The importance of ISO 14155 compliance in EU submissions Special considerations for niche and orphan devices US Humanitarian Device Exemption (HDE) pathway insights Future developments in EU pathways for rare disease technologies Strategies for managing studies with limited patient populations These experts provide crucial insights into avoiding common pitfalls in study design and execution, while offering unique perspectives on specialized regulatory pathways for rare diseases and underserved populations. Learn how to navigate these complex regulatory landscapes and optimize your submission strategy for success in both US and EU markets. --

Device Advice by RQM+
What makes a successful regulatory submission from a clinical trial perspective? (Part 2/3) – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

Play Episode Listen Later Oct 15, 2024 8:35


*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 part two of a three-part series, Jaishankar Kutty, Ph.D. continues the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Challenges in demonstrating safety and performance/efficacy for medical devices Differences between FDA and EU approaches to clinical evidence The impact of evolving device designs on clinical studies Importance of pre-submission meetings with regulatory bodies Complexities of the EU reimbursement landscape Strategies for dealing with small sample sizes in clinical data The shift in the EU regulatory landscape and its impact on manufacturers Whether you're a seasoned professional or new to the field, this discussion offers crucial perspectives on optimizing your regulatory submission strategy for medical devices and IVDs in both the US and EU markets. Don't miss this opportunity to learn from top industry experts and enhance your understanding of the regulatory review process in clinical trials! --

Device Advice by RQM+
Christine Anderson, Principal Consultant | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Oct 14, 2024 11:20


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. ⭐ After highlighting many members of our Jordi Labs, an RQM+ Company team in the past two months, we're returning to RA/QA this week. Today we're delighted to share Jaishankar Kutty, Ph.D.'s

Device Advice by RQM+
What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

Play Episode Listen Later Oct 10, 2024 21:41


*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 part one of a three part series, Jaishankar Kutty, Ph.D. hosts former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) to unpack the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Essential stakeholders in the clinical trial approval process for both US and EU markets The importance of early engagement with regulatory bodies and payers Reviewer approaches to clinical data sets and benefit-risk analyses Strategies for navigating failed primary endpoints The balance between statistical and clinical significance in regulatory decision-making Differences in approach between MDD and MDR in the EU The impact of study design and protocol adherence on regulatory review These experts provide invaluable insights into the mindset of regulatory reviewers, offering guidance on how to present clinical data effectively and navigate complex regulatory landscapes. Whether you're a seasoned professional or new to the field, this discussion offers crucial perspectives on optimizing your regulatory submission strategy for medical devices and IVDs in both the US and EU markets. Don't miss this opportunity to learn from top industry experts and enhance your understanding of the regulatory review process in clinical trials! --

Device Advice by RQM+
Michael Louis, Chemist II (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Oct 8, 2024 5:55


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.

Device Advice by RQM+
Best Practices In AE Reporting In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Oct 2, 2024 13:28


*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.*

Device Advice by RQM+
Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption Compliance

Device Advice by RQM+

Play Episode Listen Later Sep 26, 2024 67:46


This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session 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 occasional traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

Device Advice by RQM+
Effective and Efficient Safety Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Sep 26, 2024 11:25


*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 our latest clinical trials video, Manager of Safety Management Melanie Miller joins Jaishankar Kutty, Ph.D. to discuss the

Device Advice by RQM+
Anthony Grice, Chemist III (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Sep 25, 2024 8:12


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.

Device Advice by RQM+
Craig Young, Lab Coordinator (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Sep 16, 2024 11:29


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.

Device Advice by RQM+
Michael Morales, Chemist II (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Sep 12, 2024 8:04


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.

Device Advice by RQM+
How a CRO Helps with Data Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Sep 11, 2024 14:59


*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 our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the

Device Advice by RQM+
Tommy Kumlin, Chemist I (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Sep 4, 2024 6:43


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.

Device Advice by RQM+
Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Sep 3, 2024 14:10


*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.*

Device Advice by RQM+
Data Management In Clinical Trials (Setup Phase) – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Aug 28, 2024 14:01


*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.*

Device Advice by RQM+
Joshua Nott, Technical Program Lead (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Aug 27, 2024 8:33


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. Our

Device Advice by RQM+
Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2) – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Aug 16, 2024 9:03


*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.

Device Advice by RQM+
Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2) – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Aug 15, 2024 10:10


*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.

Device Advice by RQM+
Live! #81 (with FDA) – Advancing Health Equity with IVDs & Medical Devices

Device Advice by RQM+

Play Episode Listen Later Aug 14, 2024 66:15


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.

Device Advice by RQM+
Site Monitoring In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Aug 2, 2024 13:05


*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.*

Device Advice by RQM+
Site Selection In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Jul 31, 2024 13:04


*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.*

Device Advice by RQM+
Live! #80 – Beyond EtO: New EPA Regulations and Sterilization Alternatives

Device Advice by RQM+

Play Episode Listen Later Jul 18, 2024 47:42


This was recorded 18 July 2024. We encourage you to download the 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 or ⁠⁠⁠⁠⁠Events⁠⁠⁠⁠⁠ pages at RQMplus.com. Thank you for tuning in.

Device Advice by RQM+
Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

Play Episode Listen Later Jul 17, 2024 14:36


*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.* While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around

Device Advice by RQM+
RQM+ Consultant Roundtable

Device Advice by RQM+

Play Episode Listen Later Jul 16, 2024 25:59


This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients. Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance. Whether you're a professional simply interested in the field or a manufacturer interested in potentially leveraging consultant expertise, this conversation offers valuable perspectives. Chapters 00:00 - Introduction to the Team 02:23 - The Difference Between Contractors and Consultants 05:13 - Leveraging Collective Knowledge for Client Success 07:36 - Top Skill Sets for Consulting Success 14:36 - Ideal Projects and Personal Goals Panelists: Elaine M. Ruminski, MS - Senior Consultant Craig McIntire - Senior Consultant Makenzie Dorring - Consultant, CMDA Joe Commane - Consultant Scott Edwards - Managing Director --

Device Advice by RQM+
Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jul 11, 2024 19:20


*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.* Combination Device Clinical Trials: Strategy & Tactics Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video. Key topics covered: Definition and examples of combination devices Regulatory pathways in the US and EU Product development challenges unique to combination products Essential documentation for robust trial design Critical considerations for successful trial execution Highlights include: The importance of cross-functional expertise in drug and device development Crucial pre-trial steps: usability studies, risk analysis, and early stability testing Strategies for overcoming common trial execution challenges Real-world case study demonstrating the value of proactive testing Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy. Reminder that you can find all of our clinical trial videos in other places, too.

Device Advice by RQM+
Key Aspects of Medical Device Clinical Trial Design (2/2) - MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jul 8, 2024 12:44


*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.*

Device Advice by RQM+
Key Aspects of Medical Device Clinical Trial Design (1/2) - MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jul 1, 2024 12:47


*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.* ✏️

Device Advice by RQM+
Risk Management In Clinical Trials - MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jun 27, 2024 14:21


*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.*

Device Advice by RQM+
Would you like to get reimbursed? – MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jun 25, 2024 14:24


*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.*

Device Advice by RQM+
Tactics for Global Pivotal Studies – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Jun 20, 2024 21:35


*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.*

Device Advice by RQM+
Strategy for Global Pivotal Studies – MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jun 18, 2024 17:29


*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.*

Device Advice by RQM+
Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series

Device Advice by RQM+

Play Episode Listen Later Jun 12, 2024 11:40


*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.* ❓ How do you effectively

Device Advice by RQM+
Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jun 10, 2024 12:59


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. ❓ What are the CGMP principles and traceability requirements for

Device Advice by RQM+
Strategy for First-in-Human Studies (1/2) – MedTech CRO: Strategy Development Series

Device Advice by RQM+

Play Episode Listen Later Jun 5, 2024 10:34


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. ❓ What are the objectives and benefits of conducting

Device Advice by RQM+
Scott Edwards, Managing Director | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later May 8, 2024 13:57


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. "Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way." Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest

Device Advice by RQM+
Samantha Howard, Study Director (Jordi Labs) | Excellence Spotlight

Device Advice by RQM+

Play Episode Listen Later Apr 29, 2024 11:47


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.