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Obelis AG

Summary

About the company

Obelis AG provides authorised representative and regulatory consultancy services for medical devices, in‑vitro diagnostics and cosmetics, including product registration, technical documentation review, labelling and regulatory compliance support.

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Products & services

Industry:Management Consulting

✓ Offered5

Swiss Authorised Representative

Representation for non-Swiss manufacturers of medical devices; taking on the role of Swiss Authorised Representative, support with Swissdamed registration, documentation retention and notifications to Swissmedic.

Product registration

Registration and notification of medical devices with Swissmedic, including support with Swissdamed registration of economic operators and devices, as well as compliance with registration deadlines.

Technical documentation

Review of technical documentation for medical devices, including conformity assessment, retention for inspections and support with the PMS plan, PMS report and SSCP.

Swiss advisory, law and training

Advisory services for market entry in Switzerland, review of CH labelling and technical documentation, ongoing regulatory updates and support for market strategy and training.

Swiss Marking

Support in obtaining the Swiss marking for medical devices; review of the requirements for Swiss or CE labelling and accompanying conformity labelling.

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Obelis AG

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Obelis AG

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