PMS framework and data map
Objectives, responsibilities, data sources, frequencies, quality checks, installed-base denominators and interfaces with risk, clinical, security and CAPA systems.
Post-Market Surveillance
Post-market surveillance for medical device software.
We help SaMD manufacturers design and document proportionate complaint, signal, vigilance, trend and lifecycle-review processes. The scope is advisory and documentation-focused unless operational responsibilities are expressly agreed.
Selected clients
Healthcare teams we have supported
Scope and deliverables
Post-market work included in the service.
Manufacturers retain legal reporting and decision responsibility. We can support assessment frameworks and records, but do not imply 24/7 surveillance, authorized-representative status or submission of reports unless specifically contracted and legally appropriate.
Complaint and event triage
Intake fields, duplicate handling, severity and causality prompts, investigation logic, reportability escalation and controlled decision records.
Signal and trend methods
Expected-event baselines, thresholds, stratification, data limitations, review cadence and escalation criteria proportionate to available volume.
Regulatory reporting support
Decision aids and documentation inputs for FDA MDR, EU vigilance and trend reporting, field actions and applicable Indian materiovigilance obligations.
Periodic reporting documentation
EU PMS report or PSUR structures, benefit-risk updates, sales and population estimates, CAPA summaries and PMCF interfaces where applicable.
Software lifecycle feedback
Link signals to risk files, cybersecurity monitoring, clinical evaluation, anomaly assessment, CAPA and regulatory change evaluation.
Ways to work together
Choose the support your team needs.
PMS system design
Create or remediate the process architecture, procedures, templates, roles and evidence flow.
Periodic report support
Structure and draft manufacturer-reviewed PMS, PSUR or lifecycle summaries from supplied and validated source data.
Focused event support
Help organize facts, risk and reportability analysis for a defined issue; legal deadlines and submissions remain clearly assigned.
How it works
Our process.
- 1
Map obligations
Identify products, markets, classes, reporting rules, roles and available data.
- 2
Design controls
Define intake, triage, signal, investigation, reporting and escalation workflows.
- 3
Operationalize
Create records, train assigned owners and test handoffs using realistic scenarios.
- 4
Review and improve
Assess outputs, reconcile trends and update risk, clinical, CAPA and product controls.
Regulations, standards and guidance considered
EU MDR Articles 83–92EU MDR Annex IIIFDA 21 CFR Part 803FDA 21 CFR Part 806ISO 13485:2016ISO 14971MDCG 2022-21Medical Devices Rules, 2017
Frequently asked questions
Questions teams ask before they begin.
What is the difference between PMS and vigilance?+
PMS is the systematic lifecycle process for collecting and evaluating experience from marketed devices. Vigilance is the subset of regulatory reporting and action for specified serious incidents, field safety corrective actions and related events. Exact terms and thresholds vary by jurisdiction.
Do all EU devices need a PSUR?+
No. Class I manufacturers prepare a PMS report and update it when necessary. Class IIa, IIb and III manufacturers prepare a PSUR, with update and availability or submission obligations that differ by class and device situation.
Does EUDAMED now receive every EU vigilance report?+
Not yet by default. The vigilance/PMS module has its own functionality notice and transition date. Until mandatory use applies, manufacturers follow the relevant national reporting processes and current Commission guidance.
Can automated analytics decide reportability?+
Automation can flag records and support consistency, but reportability depends on facts, definitions, causality, outcomes and jurisdiction-specific rules. Qualified review and documented decisions remain necessary.
Will Predetics monitor our product continuously or file reports for us?+
Not unless a specific lawful operational scope, coverage model and responsibilities are agreed. Our standard capability is system design, assessment support and documentation; the manufacturer retains deadline tracking, authority accounts and legal accountability.
Can PMS prevent all incidents or recalls?+
No. PMS improves detection and response but cannot eliminate product risk or guarantee that field action will never be needed. Conservative escalation and timely corrective action are part of an effective system.
Start with the product you have