The RA QA Café

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 an...

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 del...

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 AKR...

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 Notif...

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...

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 insights into Risk Management Systems and best pra...

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. Join our hosts for the eighth installment of the NAM...

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 replacing the EU’s former Directive on in vitro diagnost...

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 pertaining to In Vivo study expectations in different glob...

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 RAPS, including: Highlights and takeaways from the R...

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 important during evaluation of safety and effecti...

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 delve into the differences between SiMD and SaMD, as...

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 be accepted for substantive review. Also discusse...

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 small startups, our guest speakers help highlight...