On Thursday, 26 January 2023, RQM+ subject matter experts hosted episode #63 of our Live! show. Fill out the form to get access to the on-demand recording now.
The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations are increasingly more complex.
An efficient and scalable regulatory strategy is now more important than ever. As regulatory bodies worldwide update and enforce regulations at an accelerated pace, the need for speed and flexibility in regulatory functions has never been more critical. The alternatives are failed and damaging regulatory submissions that could ultimately stop a product from coming to market.
In this RQM Live! show, our panelists will bring their unique perspectives on the world’s largest regulatory markets, the US FDA and EU MDR/IVDR.
Our subject matter experts will:
- Discuss the greatest challenges in regulatory submissions to the FDA and notified bodies
- Provide advice on how to overcome these challenges
- Identify synergies and differences between EU and US regulators
- Provide top tips for successful product submissions and interaction with EU/US regulators
Please join us! We hope our advice will help you throughout your year.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
- Carlos Galamba, MSc – Vice President, Intelligence & Innovation – IVD
- Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
- Jon Gimbel, Ph.D. – Vice President, Technical
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