Medical Devices.
Validated processes and complete evidence for every critical characteristic.
Trusted by medical device manufacturers working under validated processes.
… and many more
Medical device work is validated end to end.Every change has to stay documented and defensible.
Validated processes, controlled changes and complete documentation. A component is only usable once the evidence behind it is complete and traceable.
Documentation has to connect requirements, decisions and proof, so an audit can be answered from the record instead of from memory.
Capabilities, certifications and process validation need to be reviewable early, not after the first rejected batch.
Critical characteristics need clear planning and execution logic, from first article through to series production.
Incoming inspection needs drawing context, supplier history and evidence in one place to make a fast, defensible call.
Drevise solves the industry workflow.One understanding, every department.
One shared technical understanding of the component, used differently by each team that has to sign it off.
What our customers sayacross medical device manufacturing.
One shared technical understanding — here is what it changes for each team working under validated processes.
Your technical data stays under your control.
EU hosting, GDPR-compliant processing and flexible deployment options up to on-premise — technical data is the most sensitive asset in a supply chain, and it is treated that way.
Your data is stored and processed exclusively in European data centres.
Processing agreements, deletion concepts and access rules follow EU law.
Shared cloud, dedicated private cloud or fully on-premise in your own network.
See what the evidence trail looks like on your own component.
Send us one drawing under your usual requirements. We will show the critical characteristics, the inspection effort and the documentation Drevise derives from it.