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Medical Products

The SGS Group offers comprehensive services regarding laboratory testing, certification and evaluation for compliance with the Medical Devices Directive. Our SGS-TÜV Functional Safety team 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

SGS-TÜV Saar GmbH

  • Gudrun Neumann
  • t +49 89 787475 - 216
  • f +49 89 787475 - 217
  • e This email address is being protected from spambots. You need JavaScript enabled to view it.

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SGS-TÜV Saar GmbH

t +49 6897 506 - 60

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