Healthcare & Medical Devices
Medical Devices in the European Union not only make a significant contribution to the overall well-being of EU citizens, they also represent over 1/3 of the global marketplace for medical devices and in-vitro diagnostics (€110 billion in sales).
Obelis offers a complete range of Regulatory services to provide you with the solutions to successfully introduce your medical devices to the European market and ensure continuity. Among other things, our team of experts will guide you on:
- Permitted claims and regulatory advice
- QMS implementation and/or improvement
- Product safety consultancy
- Product testing and certification services referrals
- Identification of proper classification
- Identification of EU harmonized standards and National additional requirements (if any)
- Post market surveillance assistance
- Regulatory advice and updates
- MDR / IVDR Gap Analysis
- Be covered and prepared in case of any Regulation or Political change (e.g. Brexit)
We support manufacturers to place safe products on the EU Market, the largest in the world.