This webinar aims to guide medical device manufacturers through the intricate process of launching products in the European Union and the United States. Attendees will gain insights into the regulatory landscapes of both regions, understand the critical differences, and learn strategic approaches for successful market entry. Topics covered will include regulatory compliance, market access strategies, and post-market surveillance requirements.
Key Topics:
- Overview of the EU Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) requirements. Differences between markets.
- Strategies for navigating the regulatory approval process in the EU vs. the US
- Understanding the EU's CE marking process and the US's premarket approval (PMA) or 510(k) clearance
- Post-market surveillance and vigilance requirements in the EU and US
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Speakers:
Ann Vankrunkelsven, RAQA Manager Matrix Requirements
Who Should Attend:
This webinar is designed for medical device manufacturers, regulatory affairs professionals, quality assurance specialists, and anyone involved in the medical device industry looking to expand their market presence in the EU and the US.
Some helpful resources:
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