Free tool · medical device audits
A shared workspace for the audit.
Document requests, evidence and decisions in one place, for both sides of an ISO 13485 or MDR assessment. No chasing attachments through email, and a complete record at the end of it.
Free to use. No account to create — we email you a sign-in link.
The auditor
Raise what you need
One list of requests instead of a thread. Each stays open until the evidence answering it has been reviewed and accepted.
The manufacturer
Answer it in one place
See exactly what is outstanding, attach the document against the request it answers, and know the moment it has been accepted.
Both
Keep the record
Every request, response, file and decision is dated and attributed. Nobody has to reconstruct the audit from an inbox afterwards.
About your data
Audit evidence is commercially sensitive, so the tool is built to hold as little of it as possible for as short a time as possible. Each audit is reachable only by the two parties in it, files are never public, everything is stored in the EU, and you can destroy an audit and its documents outright whenever you want.