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SGS offers a comprehensive range of functional safety services in relation to international standards for medical devices.

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Medical device manufacturers must demonstrate that products, software and hardware, comply with the Medical Devices Directive 93/42/EEC (MDD). Failure to do so not only limits the potential market for goods, but also has potentially disastrous consequences for patients, medics and the brand, in the event of a product not performing correctly.

Functional Safety Services for Medical Products

Meeting the demands of this important sector, we offer a broad range of services to ensure that medical products comply with the MDD. These include laboratory testing, certification and evaluation. As an accredited functional safety body, SGS also evaluates:

  • Compliance with IEC 60601-1 3rd Edition
  • Programmable electrical medical systems IEC 60601-1-4
  • Software-life cycle according to IEC 62304
  • Compliance with IEC 61508

Software Applications

In addition, we help manufacturers of medical software applications (or ‘apps’) with the CE Conformity Declaration, in accordance with, Annex VII of the MDD. We can also perform an app test and, if appropriate, approve the issuing of a medical app certificate. Our experts provide:

  • 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

Bring medical devices to market with functional safety testing and certification services from SGS. Contact us today.