The RA QA Café

Human Factors: Real Life Testing for Real Life Experiences

In this episode of the RAQA Café podcast, our host explores the rapidly expanding field of human factors testing with two renowned experts—Dr. Caoimhe Duffy (Assistant Professor, Anesthesiology and Critical Care) from the Hospital of the University of Pennsylvania and Dr. Victoria Barnosky (Clinical Outcomes Consultant) from SUAZIO, now part of NAMSA. Tune in to learn about the vital importance and the intricate challenges involved in assessing how users interact with medical devices. _“We all know that processes or workflows we’re doing here in the US are very different in other areas. There might be different ways that users are using devices in certain countries…and so that’s one of those challenges of performing human factor testing in a real-world environment is being able to prove that these users are a subset or a simulation of what you would be seeing in real life.”_ – Dr. Victoria Barnosky Key Discussion Topics: * The future of human factors testing * How to identify and analyze use risks * Standardization vs. unique device requirements * Disconnect between manufacturers and users

Episode 13: Updates on the IVDR

In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry. Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD. “I think manufacturers have to be very careful when they look at the dates. It's not actually that far, because if you work backwards, like 2025 is actually. If you can't 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.” -Christelle Perrin-East, Sr. Regulatory Consultant Key Discussion Topics: * The IVDR Extension * Lessons from the MDR * Negative Impact of the IVDR Extension * Impact on Existing Products Covered by the IVDD Links: Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR [https://namsa.com/navigating-the-transition-understanding-the-eus-proposed-amendments-to-ivdr/] Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance [https://namsa.com/mdcg-2022-11-rev-1-urgency-for-mdr-and-ivdr-compliance/] RAQA Café Podcast – The EU IVDR: What Do You Need to Know? [https://namsa.com/resources/podcasts-and-videos/ra-qa-cafe/the-eu-ivdr-what-do-you-need-to-know/]

Episode 12: The Relationship among Risk Management, Clinical Evidence and Post Market Reports

Join us as we welcome two esteemed members of NAMSA’s Medical Writing team, Dr. Beatriz Rodriguez Grande and Dr. Sean Bird, for an insightful conversation on the intricate relationship between Risk Management, Clinical Evidence and Post-Market reports. Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinical Research Scientist in 2010, joined NAMSA via AKRN Scientific Consulting in 2021. She now leads as Team Leader for Medical Writing Services and Manager Consulting GTC. Dr. Sean Bird started his career at Cook Medical as a Regulatory Scientist in 2012 and transitioned to NAMSA in 2021, where he serves as a Principal Medical Writer. Together, they bring a wealth of knowledge on the regulatory requirements of medical writing in our industry. Throughout our conversation, we examine the information shared among risk management, clinical evidence and post-market surveillance. We also share strategies for maintaining consistent messaging and emphasize the importance of making sure your reports properly document your product’s requirements and how those requirements are met. “… know when you will be able to integrate the information in an efficient way so that you don't duplicate efforts.” – Dr. Beatriz Rodriguez Grande “The CER is supporting the presence on the European market, European Healthcare is the government, right? So, what is the benefit of this device? Why is this company or country paying for the device, what is the benefit?” – Dr. Sean Bird Discussion topics include: * Tailoring your documentation to your targeted audience * Coordinating information and actions * Benefit/risk strategies * Setting the bar and demonstrating you’ve met it through data-backed evidence Links: Clinical Data Requirements Under MDR: A Panel Discussion | NAMSA [https://namsa.com/events/clinical-data-requirements-under-mdr-a-panel-discussion/]

Effective Communication with your Notified Body

In this episode of NAMSA’s RAQA Café Podcast, we are excited to welcome back two esteemed members of the NAMSA team—Paul Risborough, B-Eng (Hons) (Principal Regulatory Consultant) and Matt Royle, PhD (Principal Regulatory Consultant)—to discuss aspects of effectively communicating with Notified Bodies. Both Paul and Matt bring a wealth of experience to the table, having previously worked for Notified Bodies themselves. They have since leveraged their knowledge to aid numerous NAMSA clients in navigating the nuanced interaction process with their respective reviewers. “You know the review system should be you get the first round of questions to answer. If you get a second round, it’s because you know you didn't answer the first round properly.” – Paul Risborough Discussion topics include: * Communication between manufacturers and Notified Bodies * Reviewing and responding to reviewer questions * Maintaining good relationships * Dispute resolutions

Episode 10: Talking Risk with Dr. Naveen Agarwal - Part 2

In the tenth installment of NAMSA’s RAQA Café Podcast, our hosts continue their conversation from the previous episode, “Talking Risk with Dr. Naveen Agarwal – Part 1,” with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC). This episode focuses on how to maintain a Risk Management System and shares industry best practices that our experts have acquired over their years in the MedTech sector. As a passionate advocate for risk management, Dr. Agarwal’s mission is to uplift the overall capability in risk management within the MedTech industry to accelerate innovation and launch highly safe and effective products for patients and doctors alike. “A Risk Management System is not documentation…, make sure you have a process in place, make sure you have management responsibility defined, make sure you have competent people, … then we talk about how you document a risk management plan and a risk management file… The documentation is just an output of a Risk Management System” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC) Discussion topics include: * Developing and maintaining a Risk Management System * Having a quality risk mindset * Focusing on integrating risk management as a process and not a document [https://www.linkedin.com/in/naveenagarwal?challengeSource=AgHT6qHb21gu2AAAAYrXP3YuGV9kX9IlQKBKpjqXY6nLPywcCAEHeAq7LrrxNkQ&challegeType=AgHSErPyTB9s6gAAAYrXP3Yx4air3HmLpGFu-we85ZpQF0BsNJeEmNM&memberId=AgH0WKS27M6sswAAAYrXP3YzbN3AyX5_s1QJUAsmVIef_dQ&recognizeDevice=AgEplcfcIamsawAAAYrXP3Y2cdT0fAywZd_d-1kVVUbNNXSNFvab&challengeId=AQHO_sMRvpLFKgAAAYs6npZuevgHCz8zfzrKeMYgfrQdH_Jv5JOqfwJWogAtFvmCpK0d1HxAQyC4Xg4T1YngqREJNbi0GF0B-g&submissionId=456da740-36b7-8e17-59d8-a9f970e0442e&challengeSource=AgHYrDxLiZV4fgAAAYs6ns7UCLVyzGjhZqPsXBYRvEvY9n16LHwIbjq3XWZYDEA&challegeType=AgG3SJ3zNAfHrAAAAYs6ns7WT68918qDwbi8Kd2sjJvmLKxxshZdsxU&memberId=AgHfWgY4IHqWQAAAAYs6ns7ZbYfT28dV4afbMTLXhr94OLs&recognizeDevice=AgGE8J_9pZRsMAAAAYs6ns7cQUfkrUqHZfPIasAliMk1jW3a7COh] Helpful [https://www.linkedin.com/in/naveenagarwal?challengeSource=AgHT6qHb21gu2AAAAYrXP3YuGV9kX9IlQKBKpjqXY6nLPywcCAEHeAq7LrrxNkQ&challegeType=AgHSErPyTB9s6gAAAYrXP3Yx4air3HmLpGFu-we85ZpQF0BsNJeEmNM&memberId=AgH0WKS27M6sswAAAYrXP3YzbN3AyX5_s1QJUAsmVIef_dQ&recognizeDevice=AgEplcfcIamsawAAAYrXP3Y2cdT0fAywZd_d-1kVVUbNNXSNFvab&challengeId=AQHO_sMRvpLFKgAAAYs6npZuevgHCz8zfzrKeMYgfrQdH_Jv5JOqfwJWogAtFvmCpK0d1HxAQyC4Xg4T1YngqREJNbi0GF0B-g&submissionId=456da740-36b7-8e17-59d8-a9f970e0442e&challengeSource=AgHYrDxLiZV4fgAAAYs6ns7UCLVyzGjhZqPsXBYRvEvY9n16LHwIbjq3XWZYDEA&challegeType=AgG3SJ3zNAfHrAAAAYs6ns7WT68918qDwbi8Kd2sjJvmLKxxshZdsxU&memberId=AgHfWgY4IHqWQAAAAYs6ns7ZbYfT28dV4afbMTLXhr94OLs&recognizeDevice=AgGE8J_9pZRsMAAAAYs6ns7cQUfkrUqHZfPIasAliMk1jW3a7COh] Links: [https://namsa.com/implementation-of-iso-14971-risk-management-standard/] Naveen Agarwal, Ph.D. | LinkedIn [https://namsa.com/implementation-of-iso-14971-risk-management-standard/] Effective Implementation of EN ISO 14971 Medic [https://namsa.com/implementation-of-iso-14971-risk-management-standard/]al Device Risk Management Standard | NAMSA [https://namsa.com/fda-qms-regulation-update/] Industry Update: U.S. FDA Qua [https://namsa.com/fda-qms-regulation-update/]lity Management System Regulation | NAMSA Let's Talk Risk! [https://naveenagarwalphd.substack.com/]