Expertise.
Post-Market Clinical Follow-up (PMCF).
Current?
Compliant?
Effective?
Ensure your product quality in the long term with a structured PMCF concept.
Post-Market Clinical Follow-up (PMCF).
Post-market clinical follow-up (PMCF) is an indispensable part of the product life cycle of medical devices and in-vitro diagnostics (IVD). According to MDR requirements, products that have already been approved must collect, analyze and update clinical data in order to continuously prove their safety and efficacy. We support medical device and IVD manufacturers in planning and implementing PMCF strategies to meet regulatory requirements and maintain patient safety.
Our services include PMCF planning and study design, systematic data collection and monitoring, detailed data analysis and the preparation of MDR-compliant documentation and reports.
Post-Market Clinical Follow-up (PMCF) - Sustainable safety in use.
PMCF concept and protocol.
- Development of a holistic PMCF strategy, tailored to product class and risk
- Design of the study or observation formats (e.g. prospective studies, register data, retrospective analyses)
- Integration of PMCF activities into your existing quality management system
Clinical data collection and monitoring.
- Development of structured data collection processes and tools
- Monitoring product-specific results and side effects on the market
- Collaboration with users, clinics and research institutions
Continuous evaluation and reporting.
- Systematic analysis of collected PMCF data (e.g. safety, efficacy, performance)
- Updating your risk assessments, clinical evaluations and approval dossiers
- Preparation for audits and inquiries from authorities
Case Studies - Successful PMCF in medical technology.
Challenge.
Following successful CE certification, a medium-sized medical technology company had to prove the long-term safety and performance of an innovative implant.
Measures.
- Development of a comprehensive PMCF study protocol adapted to MDR requirements.
- Introduction of an implant register in cooperation with leading clinics.
- Regular data collection through follow-up examinations over several years.
Results.
- Reliable data on the long-term safety and complication rate of the implant.
- Timely adjustment of the risk assessment based on real-time data.
- Improved product compatibility through continuous data analysis.
Success.
Thanks to the seamless collection of data, the company was able to easily meet regulatory requirements and secure international market approval.
Improve your PMCF strategy.
Our PMCF service portfolio: Comprehensive support for your medical devices.
Strengthen the safety of your medical devices even after approval.
Related topics to Post-Market Clinical Follow-Up.
Post-Market Clinical Follow-up (PMCF) is only one part of the comprehensive monitoring of medical devices after market launch. The following topics optimally complement PMCF activities and support sustainable compliance and risk minimization