Regulatory / Compliance Engineering

Applied Concepts Engineering ensures the engineering design meets all regulatory requirements.


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compliance

Our team is well versed and experienced with these regulatory documents:


  • IEC60601-1 3rd Edition - Medical Design Standards
  • IEC60601-2
  • IEC60601-2-10
  • IEC60601-1-11 - Home Healthcare Environment
  • IEC62304:2006 - Medical Device Software
  • ISO 14971:2007 - Risk Management to Medical Devices
  • ISO 13485:2003 - Quality Management Systems – Requirements for regulatory purposes
  • IEC62366:2007 - Usability Engineering to Medical Devices
  • DMR (Device Master Record) / DHF (Design History File)
  • FDA CFR Title 21 Part 800 (Series) - General Medical Devices
  • FDA CFR Title 21 820.30 - Design Controls