The situation

An early-stage MedTech project had substantial technical and clinical knowledge. The intended use was already reasonably clear, but the links between risks, supporting evidence, documentation and the route towards CE marking needed further development.

A suitable quality system to structure and document that development was also still missing.

My contribution

I mapped out, at a high level, how intended use, claims, risks, control measures, supporting evidence and documentation relate to one another. I also helped define the requirements for a suitable quality system.

The result

This created a clear view of what was needed from both regulatory and quality perspectives, and what required attention first. That made it possible to focus the next steps on the QMS set-up and a suitable digital solution.

Not every challenge requires a large programme. In an initial conversation, we look at what is needed and whether my expertise is the right fit.