EU MDR–compliant PMCF and PMS services for medical devices. Post-market clinical follow-up, PMS plans, reports, and lifecycle compliance support.
PMCF & PMS Services For Medical Devices
Bioexcel provides EU MDR–compliant Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) services to support continuous clinical evidence generation and lifecycle compliance for medical devices. Our approach aligns with EU MDR Articles 83–86 and Annex III, ensuring audit-ready post-market documentation.
What Are PMS and PMCF Under EU MDR?
Under EU MDR, manufacturers must establish and maintain a systematic PMS system, with PMCF forming a key component for generating ongoing clinical evidence.
- PMS monitors device safety and performance in real-world use
- PMCF proactively collects clinical data to confirm safety, performance, and benefit-risk over time
Bioexcel supports both activities in an integrated, regulator-aligned manner.
Our PMCF & PMS Capabilities
We support manufacturers across all device risk classes and clinical categories.
PMCF & PMS Services Include:
- PMS Plan and PMS Report (PMSR) development
- PMCF Plan and PMCF Evaluation Report
- PMCF surveys and registry-based studies
- Real-world data (RWD) collection strategies
- Trend analysis and signal review support
- PSUR support (where applicable)
- Integration of PMS & PMCF outputs into CER updates
EU MDR & Regulatory Alignment
All PMS and PMCF activities are aligned with:
- EU MDR Articles 83–86
- EU MDR Annex III
- ISO 14971 risk management integration
- ISO 13485 post-market requirements
Our documentation is structured to withstand Notified Body review and audits.
PMS, PMCF & Clinical Evaluation Linkage (CRITICAL)
Bioexcel ensures strong lifecycle integration between:
- PMS / PMCF ↔ Clinical Evaluation (CER)
- PMCF ↔ Real-World Evidence (RWE)
- PMCF ↔ Clinical Investigations (where required)
- Continuous clinical evidence
- Reduced NB questions
- Sustainable MDR compliance
Digital Enablement with Vigi X™
Bioexcel leverages Vigi X™, our materiovigilance and post-market compliance platform, to support PMS and PMCF activities.
- Complaint intake and assessment
- Incident evaluation and reportability decisions
- PMS data aggregation and trend analysis
- PMCF data integration
- Audit-ready post-market documentation
- CE marking under EU MDR
- Legacy device MDR transition
- Periodic CER updates
- NB findings related to post-market data
- Significant design or risk profile changes
Why Bioexcel for PMCF & PMS?
- Dedicated focus on medical devices & MDR compliance
- Strong understanding of NB post-market expectations
- Seamless integration with CER, RWE & clinical investigations
- Structured, inspection-ready deliverables
PMCF & PMS Services For Medical Devices | EU MDR | Bioexcel
EU MDR–compliant PMCF and PMS services for medical devices. Post-market clinical follow-up, PMS plans, reports, and lifecycle compliance support.