Medical Device Regulation (MDR): Post-Market Surveillance
Ensuring Continuous Safety, Performance, and Compliance Throughout Your Device Lifecycle.
Proactive Surveillance in the MDR Era
The EU Medical Device Regulation (2017/745) has fundamentally transformed Post-Market Surveillance (PMS) from a passive requirement into a proactive, continuous process. Manufacturers must now systematically gather and analyze real-world data to ensure ongoing device safety and performance. BQCIS provides the expert auditing and advisory services you need to build and maintain a fully compliant PMS system.
Core Components of Your MDR PMS System
PMS & PMCF Plan Development
Develop and maintain a robust Post-Market Surveillance (PMS) plan and a Post-Market Clinical Follow-up (PMCF) plan for each device or device family.
Data Collection & Vigilance
Implement systems for continuous data collection from the field, including mandatory vigilance reporting for serious incidents and Field Safety Corrective Actions (FSCAs).
Periodic Safety Update Reports (PSUR)
For Class IIa, IIb, and III devices, prepare and regularly update a PSUR summarizing surveillance results and justifying the device's ongoing risk-benefit profile.
Our Comprehensive MDR Surveillance Solutions
- PMS System Gap Analysis: An in-depth audit of your existing processes against the stringent requirements of EU MDR.
- Plan & Report Auditing: Independent review of your PMS plans, PMCF plans, and Periodic Safety Update Reports (PSURs) for completeness and compliance.
- Supplier & QMS Audits: Audits of your Quality Management System (QMS) and critical suppliers to ensure PMS data inputs are reliable.
- Vigilance Process Review: Evaluation of your incident reporting procedures to ensure timeliness and accuracy.
- Customized Team Training: Prepare your regulatory, quality, and engineering teams with expert-led workshops on MDR surveillance obligations.
Strengthen Your Post-Market Surveillance Strategy
A compliant Post-Market Surveillance system is non-negotiable for EU market access. Ensure your processes are robust, efficient, and ready for scrutiny.
Consult a Medical Device Expert