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Regulatory & EU MDR
Submissions are where development time is won or lost.
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
A file assembled by strangers reads like one.
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.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
Submission Strategy
Pathway selection, agency meeting preparation and lifecycle planning across several markets at once.
What that means for you
- One plan that holds across jurisdictions
- Meeting packages that anticipate the questions
- Sequencing that protects the critical path
Document Authoring
Modules, dossiers, technical documentation and responses to review questions.
What that means for you
- Written by people with scientific and clinical backgrounds
- Consistent with the strategy it sits under
- Version control and traceability built in
EU MDR & IVDR
Structured gap assessment through to remediation and notified body readiness.
What that means for you
- Findings ranked by risk with owners and effort estimates
- Remediation staffed by us if you want it closed, not just listed
- Mock review before the file goes in
Global Registrations
US, Europe, Middle East, Africa and emerging markets.
What that means for you
- Local requirements mapped before you commit
- Realistic timelines by market
- One team tracking every submission in flight
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Regions covered from one team
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How it runs
How an EU MDR engagement runs.
Gap assessment
Technical documentation, clinical evidence and post-market surveillance reviewed against the applicable annexes.
Costed plan
Findings ranked by risk, each with an owner, an effort estimate and a deadline you can put in a board pack.
Execution
Writers, engineers and QA specialists close the gaps. Most clients ask us to staff this rather than resource it internally.
Notified body readiness
A mock review and prepared responses before the file is submitted.
Questions
Questions we get asked before the first call.
Do you only advise, or do you write the documents?
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.
We already have a notified body. Can you work with them?
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.
How long does an EU MDR gap assessment take?
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.
Can you support 510(k) and PMA as well as European routes?
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.
What if our technical file is in poor shape?
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
Where to go next.
Send us one requisition.
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