Post Market Surveillance (PMS) Consulting
Post-Market Surveillance (PMS) Consulting for MDR and IVDR
Independent Post-Market Surveillance Consultants
MDRcert designs and remediates post-market surveillance systems for medical device and IVD manufacturers. PMS is where certified companies most often fall out of compliance, because the obligations start on the day the certificate is issued and nobody is chasing a deadline any more.
The requirements are explicit. Article 83 requires a PMS system proportionate to risk class, Article 84 requires a PMS plan meeting Annex III, Article 85 sets the PMS report for Class I, and Article 86 sets the PSUR for Class IIa and above. Under IVDR the same architecture sits in Articles 78 to 81.
A PMS plan is not a policy document. Annex III requires stated indicators, thresholds and methods, which means someone has to decide in advance what number counts as a signal.
Reports Built From Data You Actually Collect
The commonest audit finding is a PSUR whose conclusions are unsupported because the data behind them was never systematically gathered. A report that says no trends were identified, from a system with no defined thresholds, tells a reviewer nothing.
PSUR frequency is fixed by class: at least every two years for Class IIa, annually for Class IIb and Class III. For implantable and Class III devices the PSUR goes to the Notified Body through EUDAMED rather than sitting in your file. Missing that is a compliance failure, not an administrative slip.
We set up the collection first and the reporting second: complaint intake, trend thresholds, the Article 88 trend reporting trigger for statistically significant increases in non-serious incidents, and the vigilance route under Articles 87 to 92 for serious incidents and field safety corrective actions.
Assess
Current-State PMS Gap Assessment
Plan
PMS Plan, Indicators and Threshold Design
Build
Data Collection, Trending and Signal Workflow
Submit
PMS Report and PSUR Authoring
Maintain
Periodic Update and Vigilance Governance
What teams need before a PMS audit or regulatory review
Post-market surveillance fails in a predictable pattern. The plan exists but sets no thresholds, so no signal can ever be triggered. Complaints are logged in one system and trended in none. The PSUR is written from memory in the week before it is due.
We rebuild it in the order that produces defensible reports. Indicators and thresholds are defined first, under Annex III, because everything downstream depends on knowing what a signal looks like. Then intake and trending, then the reporting cycle. The system is wired into the ISO 14971 risk file, because clause 10 makes post-production information a required input and a PMS system that never updates the risk file is only half built.
Clinical follow-up sits alongside surveillance rather than inside it. Our PMCF documentation service covers the Annex XIV Part B side, and the two feed each other.
Is your PSUR due, or your surveillance audit approaching?
Core PMS Consulting Coverage
Testimonials
Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...
Dr. James Rodriguez
MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...
Sarah David
As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...
Ben Smith
The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...
Thomas Wright
Implementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn&#...
Maria Rodriguez
MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...
David Chen
We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...
Sarah Jenkins
Frequently Asked Questions About PMS Consulting
These are the questions manufacturers most often ask when setting up or remediating a post-market surveillance system. For the full range of regulatory support we offer, see our consulting services.
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MDRCert Regulatory Support Team
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