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Welcome to RA QA café, a conversational podcast with a couple of hosts that spend each episode talking about Regulatory Affairs and Quality Assurance topics. NAMSA is happy to bring the RA QA café to you, where each episode features NAMSA consultants and their experiences. Be sure to visit NAMSA at www.namsa.com for more information and access all podcasts and transcripts. We hope you enjoy today’s episode.
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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 IV…
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Episode 12: The Relationship among Risk Management, Clinical Evidence and Post Market Reports
43:16
43:16
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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 Preclinica…
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Effective Communication with your Notified Body
41:04
41:04
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41:04
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 experienc…
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Episode 10: Talking Risk with Dr. Naveen Agarwal - Part 2
19:34
19:34
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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 indus…
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Episode 9: Part 1: Talking Risk with Dr. Naveen Agarwal
42:01
42:01
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Risk management is an essential requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. In the ninth episode of NAMSA’s RAQA Café Podcast, our hosts sit down with guest speaker Dr. Naveen Agarwal (Principal and Founder of Creative Analytics Solutions, LLC) to discuss valuable …
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Clinical Investigations: Collecting Proof that your Device is Safe and Effective
41:58
41:58
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Clinical investigations play a crucial role in supporting regulatory submissions and must encompass the intended user and intended use environment. The U.S. Food and Drug Administration (FDA) refers to these pivotal studies as the definitive means of generating data that demonstrates the safety and effectiveness of a device for its intended use. Jo…
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In the seventh episode of the NAMSA RAQA Café Podcast, our hosts sit down with Warren Jameson (NAMSA Senior Manager of Regulatory and Quality) and examine the European Union (EU) In Vitro Diagnostic Regulation (IVDR). IVDR 2017/746 was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replac…
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In our sixth episode of the NAMSA RAQA Café Podcast, we sit down with guest speaker Jack Risdahl, NAMSA Principal Product Development Strategist and Doctor of Veterinary Medicine. During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaini…
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RAQA Café Live! - RAPS EU Convergence and effective MDR-compliant Periodic Safety Update Reports
1:00:13
1:00:13
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NAMSA and the Regulatory Affairs Professionals Society (RAPS) are delighted to host the first live edition of the RAQA Café! In this episode, our hosts will sit down with NAMSA UK-based Medical Device Regulation (MDR) experts, Matt Royle (Principal Regulatory Consultant) and Paul Risborough (Principal Regulatory Consultant) to discuss all things RA…
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IVD Special - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations
35:33
35:33
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In our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant). During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed…
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The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations
35:30
35:30
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What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist). During the discussion, they del…
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Refuse to Accept Policy and the Future of FDA Submissions
31:44
31:44
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What is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA's RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should…
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Finding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and …
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