How to Use Clinical Data for Medical Device Submissions in both
EU & US
Generation of clinical evidence for medical devices is highly impacted by local regulations.
Device manufacturers must be on top of regulations in all relevant markets before generating clinical data.
An important point that many realize too late, is that clinical data collected in medical device studies in Europe cannot be used for FDA submissions and vice versa - unless certain requirements are fulfilled.
Having this in mind when generating clinical evidence can help manufacturers to avoid launching additional clinical investigations for new markets.
In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru will share advice and insights on how you optimize your clinical strategy for multiple markets and answer common questions, such as:
What type of parallel clinical evidence strategies could you consider when drafting a clinical development plan for multiple markets?
What are some of the local requirements for clinical investigations?
How can you optimize the study design to be useful for multiple clinical submissions?
In this webinar medical device experts from both Avania and SMART-TRIAL will share insights and experience on:
- What regulations and requirements impact your medical device clinical data generation
- How manufacturers enable the use of clinical data for regulatory purposes outside of Europe
- How you can optimize your clinical strategy with your go-to market and regulatory strategy
Brought to you by SMART-TRIAL and Avania