Post-Market Surveillance Services
Comprehensive post-market monitoring and reporting solutions to ensure ongoing compliance and patient safety for your medical devices.
What is Post-Market Surveillance?
Post-Market Surveillance (PMS) is the systematic process of monitoring the safety and performance of medical devices after they have been placed on the market. It ensures that any potential issues are identified, evaluated, and addressed promptly to maintain patient safety and regulatory compliance.
Our PMS services help manufacturers meet their legal obligations under regulations such as EU MDR, FDA QSR, and ISO 13485, while providing valuable insights into product performance in real-world settings.
Key Benefits of Effective PMS
- Early detection of potential safety issues
- Compliance with regulatory requirements worldwide
- Improved product design and performance
- Enhanced patient safety and trust in your products
Our Post-Market Surveillance Solutions
Comprehensive services to meet global regulatory requirements
PMS System Implementation
Development and implementation of customized post-market surveillance systems tailored to your product portfolio and target markets.
Adverse Event Monitoring
Comprehensive monitoring, evaluation, and reporting of adverse events and field safety corrective actions (FSCAs).
Literature Monitoring
Systematic review of scientific literature and public databases to identify potential safety concerns related to your devices.
PMS Report Preparation
Preparation of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBERs), and other required documentation.
Trend Analysis
Statistical analysis of post-market data to identify trends, patterns, and potential safety signals requiring further investigation.
Corrective Action Implementation
Support in developing and implementing appropriate corrective and preventive actions based on post-market surveillance findings.
Our Post-Market Surveillance Process
A systematic approach to ensure ongoing compliance and safety
PMS Plan Development
Development of a comprehensive post-market surveillance plan tailored to your devices, risk profiles, and target markets.
Data Collection System
Implementation of systems for collecting, recording, and storing post-market data from various sources.
Data Collection System
Data Collection System
Implementation of systems for collecting, recording, and storing post-market data from various sources.
Active Monitoring
Continuous monitoring of adverse events, complaints, and other relevant data through active surveillance activities.
Analysis & Evaluation
Systematic analysis and evaluation of collected data to identify safety signals, trends, and potential issues.
Analysis & Evaluation
Analysis & Evaluation
Systematic analysis and evaluation of collected data to identify safety signals, trends, and potential issues.
Reporting & Actions
Preparation of required regulatory reports and implementation of appropriate corrective actions when necessary.
Continuous Improvement
Ongoing refinement of PMS processes based on findings, regulatory changes, and product evolution.
Continuous Improvement
Continuous Improvement
Ongoing refinement of PMS processes based on findings, regulatory changes, and product evolution.
Why Choose Our Post-Market Surveillance Services
Expert support for ongoing compliance and product safety
Global Regulatory Expertise
Deep knowledge of PMS requirements across major markets including EU MDR, FDA, NMPA, and other regulatory frameworks.
Proactive Approach
Our methodology focuses on early detection of potential issues before they become regulatory or safety concerns.
Comprehensive Reporting
Accurate and timely preparation of all required post-market surveillance reports and documentation.
Integrated Solutions
Seamless integration with your existing quality management systems and processes for efficient operations.
Ensure Ongoing Compliance and Safety
Our post-market surveillance experts will help you establish effective monitoring systems, meet regulatory requirements, and maintain the highest standards of patient safety.
Implement Post-Market Surveillance