Certifications

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System Certifications

  • System Certifications
  • MDQMS | ISO 13485 AUDIT
  • EMS | ISO 14001 AUDIT
  • OHSMS | ISO 45001 AUDIT
  • ISMS | ISO/IEC 27001 AUDIT
  • EnMS | ISO 50001 AUDIT
  • ITSMS | ISO/IEC 20000-1 AUDIT
  • BCMS | ISO 22301 AUDIT
  • FSMS | ISO 22000 AUDIT
  • QSR | 21 CFR Part 820 AUDIT
  • MDSAP AUDIT

Product Certifications

CE Marking

  • CE Marking (EU)

Medical Devices & IVDs

  • MDR | Regulation (EU) 2017/745)
  • IVDR | Regulation (EU) 2017/746

Other Directive & Regulations

  • LVD | Low Voltage Directive LVD2014/35/EU
  • MCD | Directive Machinery_2006/42/CE
  • DLS | Directive Lifts and Safety Components for Lifts_2014/33/UE
  • EMC | Directive 2014/30/UE Electromagnetic Compatibility
  • RED | Directive 2014/53/UE Radio Equipment Directive
  • NOISE | Directive 2000/14/CE Noise
  • ATEX | Directive 2014/34/UE
  • PED | Directive 2014/68/UE
  • GAR | EU Regulation 2016/426
  • PPE | Regulation (EU) 2016/425
  • TOYS | Directive 2009/48/CE
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