U.S. and European Regulatory Strategies for Asian MedTech Startups

On-demand webinar

Multimedia
Published on:
April 13, 2022

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 McNamara-Cullinane

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.

Related news

Publications June 23, 2022
Developing Data Specialist Talent: Collaboration Is Key
Companies across Pharma and MedTech need talented people to cover the range of data-related challenges. Discover what this means for developing talent throughout the industry.
Data Specialist MedTech Pharma
Multimedia June 21, 2022
Increasing Access to Genomic Testing in Europe
Listen to the episode “Increasing Access to Genomic Testing in Europe: The role of national genomic initiatives in increasing uptake of Advanced Diagnostics”.
Genomic Testing Market Access MedTech
Publications May 27, 2022
The Impact of Chip Shortage on the MedTech Sector and RAS Players
Discover the three factors driving the chip shortage, the impact, and what’s next for Robotic and MedTech industry at large.
CDMO MedTech Robotcs
Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
Biometrics Clinical Life Sciences Regulatory
News May 11, 2022
Alira Health Acquires RedCrow, an Equity Crowdfunding Platform for Healthcare Startups
We acquired RedCrow, an alternative investment platform that provides individual investors with easy access to expert-vetted healthcare start-ups. The financial terms of the transaction(...)
MedTech Patient Engagement Pharma
Events May 9, 2022
7e Journée start-up innovantes du dispositif médical
Clinical Digital Health Market Access MedTech Research & Development
Uncategorized May 6, 2022
U.S. and European Clinical Development for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
Clinical MedTech
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.