You have a validation package. We tell you whether it would survive contact with an inspector, and what is missing.
A device validated for one population, setting and measurement is not thereby validated for yours. The vendor's evidence answers the vendor's question.
This review tests the package against what your protocol actually asks the device to prove, and tells you plainly where the argument holds and where it does not.
Sponsors and CROs holding a validation package for a device that an endpoint depends on, and vendors who need to know whether their evidence will hold in someone else's protocol. It suits you if the package came from the vendor, looks thorough, and nobody has yet tested it against the specific measurement, population and setting your protocol requires.
The existing validation package in whatever form it arrived — analytical validation, clinical validation, human factors, technical file extracts. The protocol and the endpoint definitions, which are what the package is tested against. Device technical documentation and any further vendor evidence you hold. Any prior regulatory correspondence on the device, including questions already raised by a notified body, an ethics committee or an agency. If the package is thin, send it anyway — establishing what is absent is half the output.
You receive a single controlled package:
1. Endpoint-specific fitness opinion: for each endpoint that depends on the device, whether the evidence supports this measurement, for this population, in this setting, with the reasoning recorded.
2. Gap analysis: the package assessed against ISO 14971, IEC 62366-1, the FDA QMSR (21 CFR Part 820), EU MDR Annex I and ICH E6(R3), cited to clause level, with each gap traced to the requirement it fails.
3. Prioritised remediation list: what has to be closed, in what order, with effort estimates, separated from what is merely desirable.
4. Evidence index: every document you already hold, indexed with where it sits and what it proves, so the next reviewer does not start from zero.
Every assessment leaves the same controlled artefacts — a recorded decision, the reasoning behind it, and the evidence index that makes it defensible. They differ in scope. This one is one perimeter, assessed in depth.
Tell us about the device and the protocol. We come back with a written scope, price and date — no obligation.
Free, no account needed. Every service line and the framework each is written against.
