For Swiss Manufacturer we offer services
Clinical Trials
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Conducting Clinical trials in EU member state:
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pre-market phase: prior to placing on the market (for MDR and IVDR devices),
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post-market phase*
*The EU Medical Devices Regulation (MDR 2017/745, IVDR 2017/746) introduces post-market clinical follow-up (PMCF) studies for gathering post-market data about marketed device. The PMCF study provide data how device performs when it is used as intended. This obtained data proves the clinical performance of the product. Thus, to comply with the MDR/IVDR, manufacturers should carry out the PMCF studies throughout the device lifecycle.
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Our experts support clients in planning, preparing and conducting clinical evaluation for medical device.
Contact us to learn more about services for clinical trials, PMCF study to comply with MDR/IvDR and ISO 14155.
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EU AR
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Acting as EU AR (Authorised Representative within the EU) for Swiss manufacturer.
The Authorised Representative acting on behalf of the Swiss manufacturer is responsible for medical devices placed on the European market.
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