In an ever-changing regulatory landscape, you need a partner who stays on top. genae provides all the regulatory support services to guide you pre- and postmarket.
In this Q&A series:
• Which medical devices fall under the new EU MDR scope?
• Which country should I go to for my clinical trial?
• By when do I need to update the Clinical Evaluation Report (CER)?
• Are there any aspects that should be considered during the site selection process which affect the submission?
• Are sites involved in the submission process?
• How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
• Why is it important for manufacturers to focus on the health economics of their device?