Blog on Medical Device Regulation and CE Marking

Swiss authorised representatives for medical device manufacturers

11.11.2022 Knowledge

Swiss authorised representatives for medical device manufacturers

How to obtain a CE mark for a medical device

02.11.2022 Knowledge

How to obtain a CE mark for a medical device

Is my product a medical device in Europe? How to determine if your product requires medical device CE marking

16.09.2022 Knowledge

Is my product a medical device in Europe? How to determine if your product requires medical device CE marking

Class I medical device requirements for manufacturers under EU MDR

16.07.2022 Knowledge

Class I medical device requirements for manufacturers under EU MDR

Swiss medical device importers – regulatory requirements

27.06.2022 Knowledge

Swiss medical device importers – regulatory requirements

Risk Management for Medical Devices under EU MDR and ISO 14971

19.05.2022 Knowledge

Risk Management for Medical Devices under EU MDR and ISO 14971