OPTIM Associates, Inc

Resources

Tools & White Papers

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Assessment Tools

  • ISO 14971:2012, (ISO 14971:2007, Corrected version 2007-10-01), Medical Devices—Application of risk management to medical devices. 
  • IEC 62304:2006 + Amendment 1, Medical device software – Software life cycle processes
  • IEC 62366:2007, Medical devices - Application of usability engineering to medical devices + Amendment #1:2014 + Corr:2016

Audit Tools

  • 21CFR820 Subpart B - Quality System Requirements
  • 21CFR820 Subpart C - Design Controls

OUS Regulatory Links

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Public Health Links

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