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Regulatory Affairs
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.
Discover our regulatory Q&A videos:
• Which medical devices fall under the EU MDR scope?
• By when do I need to update the Clinical Evaluation Report (CER)?
• Which country should I go to for my clinical trial?
• 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?
