IEC 62304 defines the lifecycle requirements for medical device software, whether your product is software or contains software. We help you build a software process that delivers safe products without drowning your team in process for its own sake.
IEC 62304 specifies the lifecycle processes for the development and maintenance of medical device software. It applies to standalone software (SaMD) as well as software embedded in a device.
The standard is risk-based. The depth of process you apply scales with the software safety class: A, B or C. The higher the potential for harm, the more rigour the standard expects.
From safety classification to a fully documented software lifecycle, we work with developers in the language they speak.
A defensible classification (A, B or C) for each software item. Get this right and you save months downstream.
Lean process that fits Agile, Scrum or hybrid teams. No bureaucracy for its own sake, just the evidence the standard expects.
We review your architecture and SOUP inventory, identifying risk control gaps before your auditor finds them.
A pragmatic V&V strategy: what to automate, what to do manually, what evidence the auditor will actually look at.
Change control, problem resolution and release process. Stay compliant while shipping fast.
Workshops that engineers actually want to attend. We meet developers where they are and translate the standard into terms that fit their workflow.
FAQ
Yes, if the app meets the definition of a medical device in your target market. Many wellness or fitness apps fall outside scope, but apps that diagnose, monitor or treat are in. Classification is the first question to answer. Absolutely. IEC 62304 is process-neutral. Scrum, Kanban or hybrid all work. What matters is that the lifecycle activities happen and are documented. We help teams map their existing rituals to the standard. SOUP stands for Software of Unknown Provenance, third-party code, libraries or operating systems where you do not control development. SOUP requires its own risk analysis, version tracking and known-anomaly management. It is the part of audits that catches teams off guard.
The second edition is expected to update safety classification, clarify SOUP handling, and align more tightly with ISO 14971 and FDA guidance on AI/ML. We are tracking it and can advise on early alignment.
FDA does not adopt IEC 62304 directly but recognises it. FDA software guidance, documentation level expectations and AI/ML considerations layer on top. We map IEC 62304 evidence to FDA expectations so you do not duplicate work.