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Regulatory & EU MDR
We plan the pathway, author the documents behind it, and stay with the file through review questions, for the US, Europe, the Middle East, Africa and emerging markets.
The problem
The common pattern is a strategy set by a consultant, documents written by contractors who never saw that strategy, and a review response drafted by whoever is still available. The result is internally inconsistent, and reviewers notice. Questions multiply, and each round costs weeks.
For device and IVD manufacturers the regulations made this worse. EU MDR and IVDR replaced the old directives with far deeper requirements for clinical evidence, post-market surveillance and technical documentation, and enforcement has tightened across Europe.
We keep strategy, authoring and defence in one team, and we write with people who have done the science rather than only read about it.
Tell us the problem. A specialist replies, not a form robot.
What we do
Pathway selection, agency meeting preparation and lifecycle planning across several markets at once.
Modules, dossiers, technical documentation and responses to review questions.
Structured gap assessment through to remediation and notified body readiness.
US, Europe, Middle East, Africa and emerging markets.
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Regions covered from one team
Client testimonials are being collected and will be published here once the clients concerned have approved the wording in writing.We do not publish quotes we have not been given permission to use.
How it runs
Technical documentation, clinical evidence and post-market surveillance reviewed against the applicable annexes.
Findings ranked by risk, each with an owner, an effort estimate and a deadline you can put in a board pack.
Writers, engineers and QA specialists close the gaps. Most clients ask us to staff this rather than resource it internally.
A mock review and prepared responses before the file is submitted.
Questions
We write. Advisory-only engagements tend to produce a report that sits on a shelf. Most of our regulatory work is authoring and remediation with a strategy wrapped around it.
Yes. We prepare the file and the responses; the relationship stays yours. We do not act as your notified body and could not, which is exactly why we can be candid about what your file is missing.
For a single device family, typically two to four weeks to assessment and costed plan. Portfolios take longer, and we would rather stage them by risk than quote a single date.
Yes. Many device clients run US and European routes in parallel, and keeping both in one team is what prevents the two files contradicting each other.
That is the normal starting point and not a reason for embarrassment. The assessment tells you how far from compliant you are in specific terms, which is more useful than a general reassurance.
Related
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