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Medical Devices & IVD
Class I to III devices, combination products and in vitro diagnostics, under EU MDR, IVDR and 21 CFR Part 820.
The problem
EU MDR and IVDR replaced the old directives with far deeper requirements for clinical evidence, post-market surveillance and technical documentation. Enforcement tightened across Europe, and notified body capacity did not expand to match. A file that cleared under the directives is not a file that clears now.
Many manufacturers responded by treating it as a documentation exercise: reformat, add a section, resubmit. That works for the easy findings and fails on the hard one, which is almost always clinical evidence that was adequate for the old regime and is thin under the new one.
The honest starting position is that your file is further from compliant than it looks. A structured gap assessment tells you how far in specific terms, and turns a vague anxiety into a costed plan with owners and dates.
Tell us the problem. A specialist replies, not a form robot.
What we do
DHF, DMR and DHR support, plus design transfer into manufacturing.
ISO 14971 files that connect hazard analysis to real design decisions.
Gap assessment through remediation to notified body readiness.
Submission strategy and authoring for the US market.
CAPA, complaints, non-conformance and supplier quality resource.
IQ, OQ and PQ for facility, equipment and software.
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Regulatory routes run in parallel without contradicting each other
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are being collected and will be published here once the clients concerned have approved the wording in writing.We do not publish quotes we have not been given permission to use.
Questions
Two to four weeks for a single device family, through to a costed remediation plan. Portfolios take longer and we would rather stage them by risk than quote one date for everything.
Yes. Response drafting is a large part of this work, and it goes better when the people answering understand why the original claim was made. Where we did not write the file, we read it properly first.
Yes. IVDR brought a much larger share of diagnostics into higher risk classes, and many manufacturers were self-certifying before. If that is you, the gap is bigger than for a device maker and worth assessing early.
Yes, and it is where our pharma and device sides both matter. The common failure is two teams running two frameworks without a shared view of which one governs.
Then we place them. Quality engineers, CAPA specialists, CQV engineers and regulatory writers are among the roles we recruit most, and the same team screens them.
Related
Judge us on the shortlist, not the sales deck.