EU MDR remediation
For manufacturers with open Notified Body nonconformities, a certification that has stalled, or a technical file that keeps coming back. We find the gaps, prioritize them, and help you prepare responses that close them.
Frameworks covered
- Regulation (EU) 2017/745
- MDCG guidance
- ISO 13485
- ISO 14971
What we support
- MDR gap assessment
- Your technical documentation and quality system checked against the MDR, with a prioritized list of what needs to change.
- Technical documentation
- Structuring and completing technical documentation so a reviewer can follow the evidence from requirement to proof.
- Clinical evaluation
- Reviewing and strengthening clinical evaluation plans and reports, including the equivalence and data gaps reviewers flag most.
- Post-market surveillance
- PMS plans, PSURs and PMS reports that match the device class and actually feed back into risk management.
- Nonconformity responses
- Root cause, correction and evidence for each Notified Body finding, written to be closed at the first review.
- Pre-audit review
- A mock Notified Body audit of your QMS and files before the real one. A consulting review, not a certification audit.
Situations we help with
- Your Notified Body has raised nonconformities and the response deadline is weeks away.
- Your clinical evaluation report has been returned more than once.
- You rely on the extended MDR transition period and need to meet its conditions on time.
- Your PMS documents exist but do not connect to risk management or the clinical evaluation.
Our role
We prepare, review and coordinate remediation work with your team. We are not a Notified Body and have no part in certification decisions, and we cannot promise a certification outcome or timeline.
Common questions
Can you guarantee our certificate?
No one outside the Notified Body can. What we can do is make sure each response addresses the finding, its root cause and the evidence, so it has the best chance of being closed.
What is a pre-audit review?
A consulting exercise that runs like a Notified Body audit, against the same requirements, so you see the likely findings early. It is not a certification audit and produces no certificate.
Do you write the clinical evaluation report for us?
We can prepare or revise clinical evaluation documents with your team, or review an existing report against the MDR and MDCG guidance and tell you what a reviewer is likely to question.
Tell us about your device and the market you are aiming for.
A first conversation covers the device, its likely classification, where you are today and the date you are working to. Every enquiry goes through Crossbridge Partners, so there is one point of contact.
Discuss your regulatory pathway