U.S. and European Regulatory Strategies for Asian MedTech Startups
This webinar is part of the free webinar series “Expanding Beyond APAC” launched to discuss the strategies, challenges, and best practices of entering new markets and scaling beyond the Asia Pacific for MedTech companies.
The webinar series is prepared together with APACMed, Asia Pacific’s regional trade association which represents manufacturers and providers of medical equipment and devices, in-vitro diagnostics, digital health; as well as local associations and other key stakeholders within the medical technology industry.
The webinar “U.S. and European Regulatory Strategies for Asian MedTech Startups” focused on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific. We examined the role of US FDA pre-sub meetings and the pros and cons of 510(k), PMA, De Novo pathways as well as the implications of obtaining EUA and breakthrough designation. We discussed the challenges of the new EU MDR and IVDR regulations and provided tips on how to work with European Notified Bodies.
WHO SHOULD WATCH THIS WEBINAR:
MedTech, digital health and IVD startups, and Small & Medium-sized Enterprises based in the Asia Pacific planning to expand commercially to Europe and North America.
WHAT YOU WILL LEARN:
- What are the alternative regulatory pathways and strategies in the U.S.
- What are the hot topics and how to streamline the submission process in the U.S.
- What are the EU MDR/IVDR requirements and impact on startups
Meet the speaker
Mary McNamara-Cullinane – Senior Vice President, Regulatory Affairs, Alira Health
Mary is an accomplished and experienced regulatory professional, drawing on 25 years of experience in the healthcare and life sciences field. Mary’s clearances include: 510k (abbreviated and special), PMA approvals, IDE approvals, De Novo, 510k submissions for novel medical devices, and 513g requests for classifications. Mary is also a frequent conference speaker and panelist on a range of topics including MedTech, regulatory affairs, and women in healthcare.