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Technical documentation and regulatory compliance

Best practices and assured quality – compliant with MDR

All our development and production activities meet the highest standards for quality assurance. In order to meet the growing regulatory demands in medical engineering and diagnostics, we have extended our product portfolio with respect to technical approval and creation of the required documentation. Your product – compliant with the new medical device regulation (MDR 2017/745 ).

  • 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 and ESD pretests within own laboratory
  • Technical documentation using medical device file (MDF) and device master record (DMR)