Compliance evidence for clinical software
Find the evidence route your product needs.
Some products need clinical-safety evidence for Health IT use. Others need lifecycle and verification evidence for medical-device software. Some may need both.
DCB0129
Selling clinical software into the NHS?
Your NHS buyer will ask for a signed safety case. We produce it: the hazard log, the Clinical Safety Case Report and our in-house CSO’s signature, with every control backed by a test on your real product.
Learn moreWhat's actually blocking you.
IEC 62304
Building a medical device?
Your notified body will ask to see every requirement verified. We run the tests on your build and hand you the traceable record, from safety classification to technical-file index.
Learn moreWhat's actually blocking you.
What we produce
One engine.
Two evidence outputs.
DCB0129 and IEC 62304 are our two primary service lines, each with its own evidence structure, gatekeeper and vocabulary.
Not sure which applies to you? We’ll tell you.
Book a 20-minute scoping call. We'll map your product to the right framework, DCB0129, IEC 62304, or both, and come back with a proposal within one working day.