PMS Support
Build a PMS System That Works as Hard as Your Device.
PMS Services Overview
PMS Planning & Documentation
We develop PMS Plans aligned with EU MDR Articles 83–86, MDCG guidance, and Notified Body expectations.
PMS Reporting (PMSR / PSUR)
We create PMSR/PSUR reports demonstrating the ongoing safety, performance, and benefit–risk profile of your device.
- PMS Reports (PMSR) for Class I and Class IIa non-implantable devices
- PSURs for Class IIa / IIb / III devices
PMS Documentation Offerings
We prepare and update PMS documentation according to MDR, MDCG 2020-7/2020-8, and Notified Body expectations.
PMS Plan Development
- PMS strategy and objectives
- Data sources and collection methods
- Evaluation methodologies and statistical approaches
- Frequency of activities and reporting
- PMCF linkage and triggers
- Feedback pathways to CER, RMF, IFU, and labelling
Data Sources Defined in PMS Plan
- Complaints and customer feedback
- Vigilance and FSCA databases
- Published literature
- Registry data
- PMCF outputs
PMS Reporting Offerings
PMS Report (PMSR) Creation
For Class I and applicable IIa devices, PMSR includes following sections:
- Safety and performance observations
- Complaint and vigilance trends
- Corrective/preventive action
- Overall benefit–risk evaluation
Periodic Safety Update Report (PSUR) Development
For Class IIa/IIb/III devices, PSUR is structured to include following sections:
- Sales/usage data analysis
- Complaint and vigilance trend summaries
- Benefit–risk determination
- CAPA and FSCA outcomes
- PMCF findings and conclusions
- Updates to CER, RMF, or labelling
NB Query Support & Remediation
- Addressing reviewer comments
- Updating PMS/PSUR documentation
- Providing clarifications and justifications
Our PMS Deliverables
PMS Plan
PMS Reports (PMSR)
PSURs
Vigilance & Complaint Trend Summaries
PMS Evidence Tables
Risk Management (ISO 14971) Updates
PMS–PMCF Linkage Justification
Have a Business Enquiry?
Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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