PMS system design
- PMS procedures, workflows and templates per MDR, IVDR and MDCG guidance
- PMS plans with data sources, indicators and thresholds
- Trend reporting methodology
- Links into risk management, CER or PER, and CAPA
PMS · Post-Market & Vigilance
Post-Market Surveillance & Vigilance
From reactive complaint handling to intelligent post-market compliance. We design PMS systems, run complaint handling and vigilance as a managed service, and write the periodic reports reviewers expect, with IntelliVigilance AI, now in pilot, supporting each step.
MDR Art. 83–92IVDR Art. 78–87MDCG 2022-21MDCG 2023-3ISO/TR 2041621 CFR 803 · 806IMDRF AE terminology
Integrated vigilance workflow
Five steps from complaint to CAPA
AI assists with intake, coding and first-pass reportability. A specialist confirms each step, and the manufacturer makes and owns the final reportability decision.
- 01
Complaint intake
All sources captured in one controlled record.
- 02
Triage & coding
IMDRF adverse event coding and seriousness assessment.
- 03
Reportability review
Jurisdiction-by-jurisdiction recommendation with rationale.
- 04
Regulatory reporting
Reports prepared within the applicable clock.
- 05
Trending & CAPA
Signals fed into trend reports, CAPA and the risk file.
PMS reporting
- PMSR for MDR Class I and IVDR Class A and B
- PSUR for MDR Class IIa, IIb and III and IVDR Class C and D
- Annual PSUR updates for Class IIb, III, C and D, at least every two years for Class IIa
- Analysis of sales, complaints, CAPA, FSCA, recalls and literature
MDR Art. 85 · 86IVDR Art. 80 · 81
Complaint handling unit
- Standardised intake of complaints from every source
- Evaluation for safety, performance and reportability
- Investigation, root cause analysis and CAPA
- Complaint data and trend analysis
- Onshore, offshore or hybrid staffing, with extended-hours coverage
Vigilance & field actions
- Serious incident reports (MIR), FSCAs and field safety notices in the EU
- FDA medical device reporting and corrections and removals
- Reporting to Health Canada, the TGA, the MHRA and CDSCO
- IMDRF adverse event coding
- Recall planning and execution support
MDR Art. 87–8921 CFR 80321 CFR 806
PMCF & PMPF
- PMCF plans for devices and PMPF plans for IVDs
- Surveys, registries and post-market studies
- Evaluation reports that update the benefit–risk conclusion
Real-world evidence & registries
- Retrospective cohort reviews
- Patient and user surveys: questionnaire design, sampling, collection and analysis
- Device registry development and management
- National registry and EHR data integration
India post-market support
- CDSCO documentation for investigational medical devices and IVDs
- Safety monitoring and patient safety analysis
- Adverse event reporting to Indian authorities
Post-certification lifecycle
- Licence renewals and change notifications
- Technical documentation updates and Notified Body correspondence
- Regulatory intelligence alerts on changing requirements
- Lean, automated PMS processes that reduce manual effort
Service models
Complaint handling, the way your organisation needs it
Managed service
Complaint handling unit
We run intake, evaluation, coding and reportability preparation end to end, against agreed service levels.
Co-sourced
Extension of your team
Our specialists work inside your system and procedures alongside your own staff.
Surge support
Backlog and peak cover
Time-boxed support to clear backlogs, prepare for audits or cover a field action.
Responsibilities
Who does what
Manufacturers keep their legal obligations. We make sure the work behind them is done well and on time.
| Activity | Manufacturer | MedoQi |
|---|---|---|
| Complaint intake and logging | Accountable | Performs |
| Evaluation and IMDRF coding | Approves | Performs, AI-assisted |
| Reportability decision | Decides and owns | Recommends with rationale |
| Report submission | Legally responsible | Prepares; submits where authorised |
| Investigation, RCA and CAPA | Owns | Supports |
| Trending and PMS reports | Approves | Performs |
Reporting clocks
Jurisdiction timelines at a glance
Maximum periods from awareness. Report sooner where the regulation requires it.
| Jurisdiction | Event | Deadline |
|---|---|---|
| EU MDR / IVDR | Serious public health threat | 2 days |
| EU MDR / IVDR | Death or unanticipated serious deterioration | 10 days |
| EU MDR / IVDR | Other serious incidents | 15 days |
| US FDA | Event needing remedial action, or on FDA request | 5 work days |
| US FDA | Death, serious injury or reportable malfunction | 30 days |
| Health Canada | Death or serious deterioration | 10 days |
| Health Canada | Could cause death or serious deterioration if it recurred | 30 days |
| Australia TGA | Serious public health threat | 2 days |
| Australia TGA | Death or serious deterioration | 10 days |
| Australia TGA | Near adverse event | 30 days |
Summary for orientation only. Confirm requirements against the current regulation text and guidance for each market.
Talk to our experts
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.