Software V&V for the Medical Device Industry

Software V&V activities should be compliant with the FDA Guidance General Principles of Software Validation. This guidance recommends that the software development life cycle be fully integrated with risk management (ISO 14971) activities. Based on the intended use and the safety risk associated with the software to be developed, device manufacturers should determine the specific approach, the combination of techniques to be used, and the level of rigor that is appropriate.

While the guidance does not endorse a specific software life cycle model, it does recommend that software validation and verification activities be conducted throughout the entire software development life cycle.

When software is developed by someone other than the device manufacturer (e.g., a third-party, or off-the-shelf software) the third party is often not directly responsible for compliance with FDA regulations. Device manufacturers need to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts (if any) are needed to establish that the software is appropriate for the device manufacturer’s intended use. Ultimately, the device manufacturer is responsible for all of the software embedded within medical devices that bear their company’s name.

FDA defines software verification and software validation as follows:

Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated.

Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. FDA considers software validation to be "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled."

Understanding the essential principles of software verification and validation is critical for developing an integrated process that addresses verification, validation and risk in a timely and cost-effective manner.

I have over 35 years of experience performing software V&V and over 20 years working with software-based medical devices. During this time, I have helped dozens of device manufacturers successfully implement effective software V&V processes.

Working collaboratively with your staff, we can develop cost-effective solutions that are fully compliant with applicable regulations and guidance documents and at the same time, help your company achieve critical business objectives.