Regulatory change, mapped and carried through
When a regulation or standard changes, I map how the change affects your system and files, and implement it together with the team: the transition to FDA QMSR, the transition from MDD to EU MDR, or a new edition of a standard.
Three situations where this works best
The FDA now inspects against QMSR, which aligns 21 CFR Part 820 with ISO 13485.
Your device is on the market under the MDD transition, and the move to EU MDR has a deadline.
A new edition of a harmonized standard requires a gap analysis and changes to procedures and files.
The FDA moved to QMSR
You are still under the MDD
A standard you follow has a new edition
You're not sure which procedures the regulatory change affects.
Your transition plan to MDR was written a few years ago and hasn't been updated.
Your system was built for the old Part 820 and hasn't been reviewed against QMSR.
A new version of MDSAP or a new edition of a standard was released, and no one has mapped out what needs to change.
You need a plan the team can work through alongside its daily work.
You probably need this if one of these sounds familiar
The change in place before the next audit
What the change requires, compared with what you have today.
The changes in order, with owners and dates.
Procedures, records and technical documentation updated and put into practice with your team.
Evidence that the change is in place when the auditor asks.
Gap Analysis
A plan
The change carried through
Ready for the next audit
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
When MDSAP moved from version 10 to version 11 of its audit approach, I updated the procedures of a company I work with so they would match the new version. For a dental navigation company I support on an ongoing basis, I prepared a transition plan to the FDA's QMSR. I'm already conducting audits for companies that made these changes, to check that they work in practice.
Keeping up when the rules change
Yes. I align the quality system and the technical documentation with MDR, update PMS and vigilance, and prepare you for the notified body audit.
ISO 13485, EU MDR, EU IVDR, FDA QMSR (21 CFR Part 820), MDSAP, ISO 14971 for risk management and IEC 62304 for medical device software.
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
We're moving from MDD to EU MDR. Can you help?
Which regulatory frameworks do you work with?
How do engagements typically work – project-based or ongoing?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.