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EU MDR & IVDR
The regulations replaced the old directives with far deeper requirements for clinical evidence, post-market surveillance and technical documentation, and enforcement has tightened across Europe.
Overview
We start with a structured gap assessment against your current technical file, then hand you a costed remediation plan your notified body will recognise, and we can staff the remediation itself.
Tell us the problem. A specialist replies, not a form robot.
Capabilities
Technical documentation, clinical evidence and PMS reviewed against the applicable annexes.
Findings ranked by risk, each with an owner, an effort estimate and a deadline.
Writers, engineers and QA specialists to close the gaps rather than just list them.
Mock review and response preparation before the file goes in.
Judge us on the shortlist, not the sales deck.