Regulatory Compliance

Software is Rigorously Tested and Fully Compliant with Major Medical Device Standards

State-of-the-Art Software for Medical Devices

ISO 13485:2016  | FDA  |  EU  |  IEEE  |  IEC  |  ISO  |  AAMI

Our Quality System satisfies the requirements of these major standards:

  • ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • IEC 62304:2006/AMD1:2015, Medical Device Software – Software Life Cycle Processes
  • FDA’s General Principles of Software Validation (GPSV)
  • IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle
  • ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
  • ISO/IEC 12207, Systems and Software Engineering – Software Life Cycle Processes
  • FDA CFR Part 820, Quality System Regulation
  • Good Automated Manufacturing Practice (GAMP)
  • International Society of Pharmaceutical Engineering (ISPE)
  • EU Medical Device Directive (91/42/EEC)

We look forward to talking with you!

We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!

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