POST-MARKET SURVEILLANCE GAP ANALYSIS CONSULTATION
Find Out Whether Your PMS System Will Hold Up Under Notified Body Scrutiny
Most manufacturers we speak to about PMS are partway down the road. Their plan is in place, the PSUR cycle's running, PMCF and risk management are maintained on schedule. What they're less sure about is whether all of that holds together under audit.
That's usually the real question they bring. Whether a Notified Body reviewer pulling the thread between PMS findings, PMCF outputs, CER conclusions, risk file updates and PSUR sign-off will find a system that tracks, or one that falls apart at the joins. Often the team's recently scored themselves against the audit-readiness checklist and the result has sharpened the question rather than answered it. In other cases a PSUR is approaching and the inputs feeding it don't yet feel coherent, or a previous audit raised observations and there's lingering doubt about whether the corrective actions actually closed them.
This consultation is designed to give them an earlier, independent view, before that scrutiny arrives.
What This Consultation Is
This is a structured 30-minute conversation with one of our senior post-market surveillance specialists. It isn't a report or a formal audit. It's a focused diagnostic discussion intended to identify where your PMS system carries the most exposure under the relevant regulatory frameworks, be that MDR Articles 83 to 86 and Annex III, UK requirements or other international expectations, and how serious the underlying issues are likely to be.
During the consultation, we will:
Review the structure of your PMS Plan, your PMS governance, and how PMS findings flow into PMCF, CER, risk management and PSUR
Consider the integration points between these documents and where evidence threads are most likely to break
Identify the specific structural weaknesses a Notified Body reviewer is most likely to surface
Discuss proportionate remediation options, including which gaps need immediate attention and which can be sequenced
Advise honestly whether a full PMS Gap Analysis engagement would add value, or whether the issues can be closed internally
We won't conduct detailed document review during the session itself. The aim is to give you a clear, expert read on where you stand and what the realistic remediation pathway looks like.
Who Will Find This Most Useful
You don't need a fully matured PMS system to benefit from this session. You do need to be at a stage where understanding your post-market surveillance risks actually matters to your timeline.
This consultation tends to be most useful for:
Regulatory, Quality or Clinical Affairs leaders
…who own the PMS system and want an independent expert read before the next audit cycle
Manufacturers approaching PSUR submission
…where the PMS, PMCF and risk inputs feeding the report don't yet feel coherent
Teams who've recently scored their system
…using our PMS Audit Readiness Checklist or otherwise, and want to discuss the highest-risk findings with a specialist
Organisations who've received Notified Body observations on PMS, PMCF or PSUR
…and want to be certain the corrective actions will close them properly
Manufacturers in scale-up mode
…whose PMS system was designed for a smaller portfolio and is now creaking under additional devices, indications or geographies.
If you're at an earlier stage and still building your PMS plan from scratch, this consultation may not be the right starting point. We'll be honest about that on the call.
What to Bring
To get the most out of the 30 minutes, it helps to have the following to hand. You don't need to send them in advance.
Your current PMS Plan and most recent PMS Report or PSUR
Your PMCF Plan and most recent PMCF Evaluation Report
A summary of how your Risk Management File is updated from PMS and PMCF inputs
Your most recent PMS Audit Readiness Checklist scoring, if you've completed one
A short description of the device, its classification, and which Notified Body holds the certificate
We won't read these documents during the session. They're reference points so the conversation can stay grounded in your actual system.
What You Leave With
By the end of the consultation, you'll have:
A clear view of where your PMS system carries the most audit exposure, framed in the language a Notified Body reviewer would use
An understanding of which weaknesses are structural and which are presentational
A clear sense of what remediation would involve, including likely effort and sequencing
Direct expert input on whether a deeper PMS Gap Analysis engagement is warranted, or whether your team can close the gaps internally
If your PMS system is already well aligned, we will confirm that clearly. This session is about accuracy, not creating work.
Where This Sits in Your Surveillance Strategy
PMS is the part of the regulatory system where small structural weaknesses compound quickly. A PMS Plan that reads well in isolation can still fail audit if the data it generates doesn't feed PMCF, CER, the Risk File and the PSUR in a way a reviewer can follow.
This consultation exists because most teams already sense where their system is weakest. They want a senior, independent voice to confirm or challenge that view, before they commit time and budget to the execution of a flawed plan, or remediation that may or may not be the right priority.
Discuss your Post-Market Surveillance Gap Analysis
Select a time to discuss your current PMS position
A Note on Fit
Not every manufacturer needs this consultation. If your PMS system has recently been audited cleanly, if your PSUR and PMCF cycles are integrated and well-evidenced, and if your Risk Management File reflects post-market inputs in a traceable way, you may not benefit from booking time with us. We'd rather tell you that upfront than take a meeting that doesn't help.
If you're unsure whether your system is in that position, the consultation itself is the fastest way to find out.
Not Ready for a Consultation Yet?
If you'd like to assess your own PMS system before booking, our diagnostic checklist walks you through eleven structural sections of the MDR post-market surveillance lifecycle. It scores your system against the patterns Notified Body reviewers actually trace, and gives you a maturity read across PMS Plan, PMCF, CER, Risk Management and PSUR.
Most teams find that the checklist sharpens the question they want to bring to a consultation.