Webinar | Navigating the Regulatory Landscape for Innovative Biomedical Application
NXTGEN Hightech Biomedical and High Tech NL invite you to an insightful webinar on September 4, 2024, from 16:00 to 17:00 CET. This engaging and practical webinar will provide hands-on advice, based on the extensive experience of QServe, a leading regulatory advisory firm. Participants will gain valuable insights into: The importance of early regulatory engagement
Essential milestones needed to prepare for the launch of your biomedical innovations.
Who is this webinar intended for?
This webinar is intended for professionals in biomedical engineering, applications and life sciences who are eager to navigate the complex regulatory landscape and successfully bring their innovations to market.
Register early, as there are only a limited number of places available for this webinar.
Programme
Welcome by Edwin Roovers, High Tech NL Life Science
How to bring your idea to market?
- In which country do I want to market my device first?
- Classification > Do I have a device?
- High-level overview IVDR, MDR, FDA
- Production and responsibilities
- Choosing suppliers, subcontractors and OEMs
Case study lab-on-chip
- Early phases what matters
- What is worth investigating
- Common mistakes
- Time versus cost
- Exit strategy