From concept to commercialization, we are dedicated to supporting your product development journey by providing you with the expertise and guidance you need to successfully navigate the complex and ever-changing landscape of global regulations to achieve regulatory approval and market access for all of your healthcare products.
Any manufacturer of medical devices or in-vitro diagnostic devices (IVD) based outside of Switzerland that wishes to place their product on the Swiss market must designate a Swiss Authorised Representative (CH-REP).
The CH-REP takes the local responsibility for formal and safety-related aspects connected with the placing on the market of the device, for example confirming that the conformity assessment procedure has been carried out, or ensuring that any serious incident reports are sent to Swissmedic.
Our regenold swiss office and experts can cover this role for you. Get in contact with us for further information about our services.
Sound & reliable foundation: regenold swiss is part of the Regenold group of companies, founded by Dr. Jürgen Regenold in 1994.
Broad knowledge: we can cover all aspects of Medical Devices, IVD, Drugs, or Drug Combination Products.
Network: we can build on regenold’s proprietary network regulanet®, consisting of partners in over 90 countries worldwide.
Local presence: we ensure compliance with local regulations and developments, also being a member of Swiss Medtech.