Traditional
innovative.

Medical products

We inspect your active medical devices for European and Global market approval and work with you hand in hand to quickly and easily create and execute an individual test plan.

  • Notified body for medical devices and in vitro diagnostics (NB 0120 and 0598)
  • Product Safety (IEC 60601-1)
  • Electromagnetic Compatibility (IEC 60601-1-2)
  • Environmental Simulation (IP/transport test/HASS/HALT)
  • Biocompatibility (IEC 10993)
  • Radio (R&TTE/FCC)
  • RoHS (IEC 62321)
  • Software (IEC 62304)
  • Functional Safety (IEC 61508)
  • Usability (IEC 62336)
  • Expert certification (GIS)

The SGS Group thus 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:

Your benefits

  • Competent service worldwide from a single source
  • Direct contacts with extensive experience in the field of medical technology

Contact

EMC and Product Safety:
t +49 89 787475 – 133
f +49 8912504064133
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Functional Safety:
t +49 89 787475 – 216
f +49 89 787475 – 217

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SGS-TÜV Saar GmbH

t +49 6897 506 - 60

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