Medical device manufacturers must obtain certification against the CE marking directive from a Notified Body before using the CE mark and placing products on the market. Our functional safety team delivers these services for active/electrical medical devices and testing in accordance with:
- IEC 60601-1 3rd Edition
- Programmable electrical medical systems IEC 60601-1-4
- Software-Life Cycle according to IEC 62304
- IEC 61508
In addition, we provide help to manufacturers of medical software applications (APPs) with their CE conformity declaration:
- Training on the procedures and requirements of the CE manufacturer declaration of Medical Device Directive 93/42/EEC (MDD), Annex VII
- Clarification of the applicable medical device standards
- Examination of documents to be submitted
CE mark and sell medical devices in Europe with medical device directive, 93/42/EEC, certification from SGS. Contact your local office today to find out more.