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
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DIN EN ISO/IEC 17025


D-PL-11020-03-01

FCC Registration
EMC absorber facilities

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Reg.-Nr. 90932,
97242, 299569

FCC approval (CAB) by Bundesnetzagentur

Bundesnetzagentur



IEC CB-Scheme CBTL Certificate

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Japan – VCCI-Registration

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Member-No. 2793





Connect With Us

SGS Germany GmbH
E-Mail: cqe@sgs.com Tel.: +49 89 787475-100

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