Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
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Under the EU Medical Device Regulation (MDR 2017/745), Post-Market Surveillance and Vigilance are no longer optional but legal obligations central to a device’s lifecycle. Manufacturers must establish a proactive, systematic PMS plan and maintain a Post-Market Clinical Follow-up where applicable, ensuring continuous evaluation of safety and performance. Vigilance requirements demand timely incident reporting, trend analysis, and corrective actions, all closely monitored by Competent Authorities.
The EU has a structured approach to PMS, as outlined in the European Medical Device Regulation. Manufacturers are required to establish a comprehensive PMS system that includes PMS Plan as a documented strategy for monitoring device performance and safety, a Post-Market Surveillance Report to summarize the findings from PMS activities, which must be updated regularly and the Periodic Safety Update Report which is required for higher-risk devices, summarizing the results of PMS activities and any corrective actions taken.
This training provides practical guidance on implementing compliant PMS and Vigilance systems, from preparing robust PSURs and PMCF reports to navigating EUDAMED reporting requirements. Participants will learn how to transform regulatory obligations into opportunities, strengthening product safety, achieving MDR compliance while driving long-term market success.
Content Overview:
- Post-Market Surveillance vs. Post-Market Clinical Follow-up
- Vigilance & Incident Management under (EU) MDR
- Transition from MDD to MDR: Key changes
- Integrating PMS and Vigilance into the QMS
- Practical Implementation
- Audits & Compliance
- Value of PMS & Vigilance
- Case studies, group exercises, and Q&A sessions
Benefit: This course offers more than regulatory interpretation. It empowers your organization to proactively monitor product safety, reduce regulatory risk, and streamline vigilance reporting. Learn directly from regulatory experts and auditors with first-hand experience in MDR compliance.
Target Audience: This training is intended for professionals involved in lifecycle management, regulatory compliance, and safety of medical devices, including Regulatory Affairs Managers, Quality Assurance Teams, Research & Development and Clinical Affair Specialists
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.
Auditors
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Klaus Lindenberg
Auditor
Klaus Linderberg graduated from Fachhochschule Lübeck as Diplom Ingenieur (FH) in Biomedical Technology. With extensive experience across various companies in Germany’s medical device sector, he has built a strong foundation in quality and regulatory compliance. He has been working as a Lead Auditor and Technical Expert for medical device Quality Management, specializing in regulatory standards and audits. His professional background is supported by certifications relevant to medical device quality assurance and auditing.