Certification - OptoBioMed

Our quality for your product - certified, tested and lived daily!

All our development and production activities meet the highest standards for quality assurance. In order to meet the growing regulatory demands (new Medical Device Regulation) in medical engineering and diagnostics, we have extended our product portfolio with respect to technical approval and generation of the required documentation.

  • Certified according to ISO 9001 and ISO 13485
  • Production is audited by FDA
  • Risk analyses according to DIN EN ISO 14971:2012                
  • Safety of laser according to DIN EN 60825
  • Electrical safety according to DIN EN 60601
  • EMC pretest and ESD pretest
Certificat ISO 9001
Certificat ISO 13485
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