The October 31, 2019 edition of MPO (Medical Product Outsourcing) features 5 Takeaways from RAPS Convergence 2019, an online exclusive written by StarFish Medical Toronto QA/RA manager Deborah Pinchev.
Subheaded “The medical device regulatory landscape is changing faster than ever and we need to keep up,” the article shares Pinchev’s top regulatory topics from the largest gathering of regulatory professionals in the world. RAPS (Regulatory Affairs Professional Society) Convergence 2019 in Philadelphia covered the fields of pharma, biotech, and most important to me, medical devices.
Deborah notes, “Right now is as great a time as ever to converge and discuss all things regulatory with other medical device folks. In fact, I kept hearing this year’s convergence contained a huge number of medical device attendees. The reason why is clear to me with the EU Medical Device Regulation (MDR) now less than eight months away, and hot topics like artificial intelligence.”
Areas of particular interest to medical device professionals include:
- MDR is not only coming, it’s already here and resourcing is a problem.
- Yes, there is the MDR—but wait, what about IVDR?
- Communication is key to any healthy relationship—that includes yours with the FDA.
- Artificial Intelligence (AI) and Machine Learning (ML)—the future is now.
Pinchev concludes with a list of “Golden Nuggets” including: “We should all get “risk-based approach” tattooed somewhere! Consider these words during every decision you make throughout the product lifecycle and regarding your quality system. This will help you identify what is truly important and will guide senior management to resource appropriately.”
Deborah Pinchev is Toronto QA/RA Manager at StarFish Medical, Canada’s largest medical device development company. Deborah has 5 years of Regulatory and Quality experience with a focus on the medical device industry. Prior to joining StarFish, she was cell biology research Laboratory Manager at Mount Sinai Hospital in Toronto. Deborah earned her B.S. in Biochemistry at the University of Guelph, her M.S. in Biochemistry and Biomedical Sciences at McMaster University, and a graduate certificate in Regulatory Affairs at Humber College. She is inspired to write blogs by her interest in helping companies develop and bring to market new and innovative devices.