Episode description
This is audio from RQM+ Live! #60, recorded 22 September, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We also answer your questions in the process!
This RQM+ Live! show discusses the biggest takeaways and surprises from this year's RAPS Convergence. We cover at least a little bit of the subject matter in each of our speaker's sessions, including:
- Clinical evaluation
- Recent developments in EU Regulations (MDR and IVDR)
- Post-market clinical follow-up (PMCF) and risk management
- Developing IVDR-compliant intended purpose statements that serve the business and meet notified body expectations
- How to efficiently prepare your eSTAR submission
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. – Vice President , Intelligence & Innovation
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Celeste Maksim, Ph.D., RAC – Chief of Staff
- Anike Freeman, M.Eng., PMP – Principal Consultant
- Nancy Morrison, RAC (moderator) – Vice President, Intelligence & Innovation
Questions with timestamps:
3:34 -- Please let the audience know what you spoke about and any key takeaways from the session?
9:24 -- This being the first year back in person after being virtual and hybrid, what did you observe about this conference? What about the attendees?
13:54 -- What was the most unexpecting thing or key learning that you took away from the conference?
24:24 -- Have you also discussed how clinical data and endpoints should be defined when a legacy device has an equivalent device that is now a similar device under MDR, where the legacy device has not yet been placed on the market?
26:27 -- What are we seeing in clinical trials?
28:08 -- What did you hear about surveys?
30:07 -- Am I going to get specifics about my type of device at this conference? Carlos, can you speak to IVD aspect?
33:29 -- How about on the device side... were there a good range of topics and product types represented on the Convergence agenda?
36:38 -- Is it a study if it's a retro chart review that collects personal health information?
40:04 -- What were your takeaways in terms of what's on people's minds and what's bothering manufacturers right now?
42:21 -- What's new with digital health?
43:53 -- How about companion diagnostics?
48:04 -- Did you hear any conflicting advice or things that you did not agree with?
55:08 -- Where is next year's conference?