Healthcare & Medical Devices
Medical products 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 advisory services to provide you with the solutions to successfully introduce your medical devices to the European market and ensure continued longevity. Among other things, our team of experts will guide you on:
- Permitted claims and regulatory advice
- QMS implementation
- Product safety consultancy
- Product testing and certification services
- Identification of proper regulation
- Identification of EU harmonized standards
- Post market surveillance assistance
- Regulatory advice and updates
- MDR / IVDR Gap Analysis
- Navigating a post-Brexit EU
We support manufacturers to make safe products available on the EU Market while gaining a foothold into the largest market in the world.