The global regulatory landscape for medical devices and IVDs is changing, which is causing many manufacturers to rethink their regulatory strategy. We frequently hear that customers now consider market access to the US first and then CE marking for Europe later.
In this webinar series Gert Bos interviewed two global registrations specialists on the 7th of September 2023 from the Qserve team. In a question-answer format, Gert, Daniëlle and Olena shared knowledge from their practical experience on the trends in the industry:
- In-country registrations in APAC, EMEA, and LATAM countries
- The different roles as an authorized rep or agent
- Current changes in the UK regulation
- How to keep a practical approach to the manufacturers' technical documentation to designing market access strategies?
- How to build a quality management system that is suitable for multiple market access?
Qserve started 25 years ago, with this webinar we guide you through the past, present regulatory environment and finally glimpse the future.
Watch the Webinar On-Demand