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Diagnostic device case study: client gained FDA approval through effective Verification and Validation

Honest and trusted quality partner

Our client is a large international company working to disrupt the current healthcare testing process with a new point of care diagnostic testing device. Their product is aimed at both the European and US markets.

They came to us seeking additional support for their development team. There was already a strong project team in place, including several outsourced partners working together to develop the new medical device.

Bluefruit Software’s role was to provide support with integration and management, mirroring the existing software development process and ensuring quality across both product functionality and adherence to regulatory requirements. As the project progressed, we also started doing full-time Verification and Validation testing and firmware development work. We did this with a team of over 12 of Bluefruit’s Software Test Engineers, Quality Analysts and Embedded Software Engineers supporting the development, working towards the launch of the new product.

The critical part of our role in this project was acting as an additional layer of quality control, ensuring thorough testing of all merged code.

Challenges Bluefruit Software faced

The project was a success, with the client able to submit and achieve FDA clearance and strong product launch, but it wasn’t without its challenges. Our team had to deal with several initial project risks:

  • Involvement at a late stage in the project
  • Coordinating across several outsourced partners
  • Meeting compliance requirements across all teams and partners
  • Extensive pre-existing requirements documentation

What our client gained

Bluefruit worked with all the different partners involved in the software development process to enhance quality, and support Verification and Validation across the various software elements.

There were multiple aims for this activity, including but not limited to:


  • Ensuring all teams met IEC 62304 during the project, generating documentation and capturing processes
  • Converting several thick pre-written specification documents that were in constant flux into a living and breathing suite of test cases, giving thorough coverage of the software
  • Delivering FDA-compliant documentation at the end of each test run (which has enabled the client to gain FDA approval)


  • Regular execution of the entire test suite, which grew to include approximately 3500 tests
  • A high standard of work, with us tracking, reviewing and revising all our work continuously
  • Immediate and high-quality reports of any issues found sent to the client during test runs
  • Developing our own suite of tools to maximise the efficiency of our processes whilst still retaining full compliance (which is how we managed to be so quick in the first place)

Coordination and collaboration

  • Working with the client to coordinate the activity of the different partners to ensure maximum effectiveness, without sacrificing quality
  • Providing clarity on the progress of the software development work against target deadlines, including regular reporting on both activity and quality
  • Working closely with the client, responding positively and quickly to their requests, while they could trust us to be open and honest with them

A successful, multi-team collaboration

Working on this project provided our teams with an excellent opportunity to take part in a multi-team collaboration delivering at scale software development and testing services to an FDA Class II standard. Throughout the project, we continued to explore, innovate and, most importantly, provide value for our client.

Working with other partners around the world also provided us with the opportunity to learn from other development teams and continue to improve and grow our tools and processes. With the product now live on the market, we are excited to watch the journey for this innovative medical company and look forward to working with them on future projects.

Find out if your medical device software is IEC 62304 ready

Are you wondering how well your device software holds up against IEC 62304? You can download your copy of The essential IEC 62304 checklist today.

The essential IEC 62304 checklist will help you:

  • Understand critical parts of the standard from a business perspective.
  • See the early signs of whether your medical device software is audit-ready or not.
  • Discover key opportunities working to IEC 62304 presents for your business.

Download your checklist and answer:

Looking for experienced software engineers and testers?

Are you looking for software development or verification and validation support for your project? We’d love to discuss how we can help. Drop us an email at [email protected] so we can set up a time to discuss your requirements.