The problem
Complaints are evidence, whether you treat them that way or not.
Every complaint is a data point about how a device performs in the field. Some of those data points start a legal clock. Under FDA medical device reporting rules most reportable events must be reported within 30 calendar days and some within 5 work days, and the EU vigilance timelines for serious incidents are shorter still. A reportability decision that waits in a queue becomes a late report.
Periodic reporting is the second problem. EU MDR expects a post-market surveillance report for class I devices and a periodic safety update report for higher classes, at least every year for class IIb and III and at least every two years for class IIa. Written as a formality, these reports miss the trends a notified body is looking for.
We set up the process so reportability is decided on time and documented, and we write the periodic reports as analysis rather than as a copy of the complaint log.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
PMS plans
Post-market surveillance plans that state what data you collect, how you analyse it and what triggers action.
What that means for you
- Data sources and thresholds defined up front
- Linked to risk management and clinical evaluation
- A plan a notified body can audit against
Complaint reportability
Complaint handling to ISO 13485 clause 8.2.2, as incorporated by FDA QMSR, and reportability decisions under 21 CFR Part 803 and EU vigilance rules, with the rationale recorded.
What that means for you
- Decisions inside the reporting clock
- A documented rationale for every decision
- Trending that surfaces signals early
PMSR and PSUR authoring
Periodic reports written from the data: sales and usage, complaint and incident trends, literature, and conclusions on benefit and risk.
What that means for you
- Analysis, not a pasted complaint log
- Consistent with the technical documentation
- On the cycle your device class requires
Field actions and CAPA
Support when trends point to a correction, removal or field safety corrective action, connected back into CAPA.
What that means for you
- Escalation criteria agreed in advance
- Correction and removal reports prepared
- CAPA records that close the loop
Engagement write-ups appear here only once the client concerned has approved the wording in writing.We do not publish client names or outcomes without that approval.
How it runs
How PMS support runs.
Process and data review
Complaint handling, data sources and past reports reviewed against FDA and EU requirements.
Plan and procedures
The PMS plan and reportability procedure written or brought up to date.
Ongoing reportability and trending
Complaints assessed on time, with trends reviewed at an agreed interval.
Periodic reports
PMSRs and PSURs written on cycle and fed back into risk management.
Questions
Questions we get asked before the first call.
Can you run complaint handling for us day to day?
Yes, as a functional service with named people, or by placing a specialist in your team. Either way the decisions stay documented in your own quality system.
How often is a PSUR needed?
Under EU MDR, at least annually for class IIb and class III devices and at least every two years for class IIa. Class I devices need a post-market surveillance report, updated when necessary. Under IVDR, class A and B devices need a post-market surveillance report and class C and D devices a PSUR, updated at least annually. We confirm the cycle for your portfolio at the start.
Do you cover US reporting as well?
Yes. Medical device reports under 21 CFR Part 803 and reports of corrections and removals under Part 806, in the same process as the EU obligations, so one event is assessed once.
We have a complaint backlog. Where do we start?
With the complaints that could be reportable. We triage the backlog by risk first, so any late reports are found and filed before anything else.
Related
Where to go next.
Is your complaint backlog growing?
Tell us how many and how old. A specialist replies with how we would triage it.