Regulatory authorized representative service for medical devices, IVDs, and PPE in Switzerland. Manages compliance, technical documentation, and market access for manufacturers across all device classifications under Swiss and EU regulations.
Manufactured by
MedNet EC-REP GmbH
Münster, Germany
With many years of experience and a highly qualified team, MedNet EC-REP offers all services for the pan-European marketing authorization of your products: the European Authorized Representative (EC-REP), the UK Responsible Person (UK RP) and the Swiss Authorized Representative (CH-REP). We specialize in medical devices, in vitro diagnostics (IVD), personal protective equipment (PPE), clinical investigations and performance studies, and application for certificates of free sale (FSC).
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Obelis Group S.A.
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Obelis Group S.A. · Belgium
Swiss Authorized Representative service for medical device and IVD manufacturers seeking regulatory compliance in Switzerland. Provides expert guidance on Swiss medical device regulations, registration requirements, and post-market obligations to facilitate market access and regulatory adherence.
MDSS USA LLC · United States
Swiss Authorized Representative service for medical devices and IVDs enabling non-Swiss manufacturers to achieve regulatory compliance and market access in Switzerland. Provides in-country representation, regulatory documentation support, and liaison with Swiss authorities to meet MDR and IVDR requirements.
TS Quality & Engineering SRL · Italy
Regulatory representation and consulting services for medical device manufacturers navigating EU MDR, UK, and Swiss regulations. Supports design control, risk management, quality system development, ISO 13485 compliance, and market authorization across multiple jurisdictions.
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