Expert Swiss Regulatory Support for
Medical Device Manufacturers
Legal background
Entering or expanding in the Swiss market without thorough knowledge of the national regulatory requirements can lead to significant delays, product refusals, or other non-compliance.
A trusted regulatory partner helps you:
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- Avoid regulatory pitfalls and administrative errors
- Accelerate market access and maintain business continuity
- Stay up to date on evolving legislation and Swissmedic expectations
- Focus your resources on sales and strategic growth instead of compliance complexities
Our services
How Obelis Support Your Regulatory Strategy
Since 1988, Obelis has been helping manufacturers confidently navigate the Swiss regulatory system. Whether you’re entering the market or expanding your operations, we provide comprehensive support through services such as technical file and QMS reviews, and gap assessments to ensure compliance with MedDO and IvDO requirements; label and language validation to guarantee packaging and instructions meet Swiss language and medical device standards. We provide market access planning with tailored strategies for Swissdamed registration and post-market surveillance. We also deliver ongoing regulatory alerts and updates based on Swissmedic announcements to keep you informed and compliant.
