The SGS Group offers comprehensive services regarding laboratory testing, certification and evaluation for compliance with the Medical Devices Directive. Our team of SGS-TÜV Functional Safety complements these services for active / electrical medical devices.
Our services as accredited body related to Functional Safety also include evaluations for:
- IEC 60601-1 3rd Edition
- Programmable electrical medical systems IEC 60601-1-4
- Software-Life Cycle according to IEC 62304
- IEC 61508
We also provide manufacturers of medical software applications (APPs) assistance with the CE Conformity Declaration in accordance with the Medical Device Directive 93/42/EEC (MDD), Annex VII:
- Training on procedures and requirements of the CE Declaration of Annex VII
- Clarification of the applicable medical device standards
- examination of the documents to be submitted
Contact:
Gudrun Neumann
Tel. +49 89 787475 – 216
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