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Incorporating software into your medical device offers a myriad of opportunities to improve patient health. However, the criticality of correct design and traceability in software development means that, more than any other function, it’s vital for software to be developed following the correct process. In doing so, the chances of a successful regulatory submission and a robust, commercial product are greatly increased.

Our Quality Management System is certified to ISO 13485:2016 and aligned to the requirements of the FDA’s Quality System Regulation (21 CFR 820). Our quality and regulatory experts are experienced in developing software which operates independently as a medical device, or which acts as part of an overall system.

The regulatory framework which we operate in includes the following:

  • ISO 13485:2016
  • 21 CFR 820
  • 21 CFR 11
  • IEC 62304
  • IEC 82304-1
  • IEC 60601-1
  • FDA guidance document “General Principles of Software Validation”
  • FDA guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”

Other relevant pages: