Medical Products
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
This email address is being protected from spambots. You need JavaScript enabled to view it.
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Related links
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Deutsche Akkreditierungsstelle
DIN EN ISO/IEC 17025
D-PL-11020-03-01, D-PL-11020-03-02, D-PL-11020-03-03
IEC CB-Scheme CBTL Certificate
USA EMV FCC
D-PL-11020-03-04
USA EMC FCC
FCC approval (CAB) by Bundesnetzagentur
USA / Canada Product Safety
Authorization for OSHA-NRTL, ISO 17065 and Standards Council of Canada (SCC)
Japan – VCCI-Registration
Member-No. 2793