Tuttlingen – All business processes of a medical technology company are subject to a risk-based approach. Accordingly, risk management is one of the most important tasks. The "Risk Manager Medical Technology" certificate course, which starts on March 15th, imparts practice-oriented knowledge and well-founded theory in order to be able to professionally implement the requirements of standards and EU-MDR.
Risk management accompanies the entire life cycle of a medical device, from the first drafts to post-market surveillance. The certificate course shows the basic conditions and deliberately focuses on practical examples. They clarify how processes should be structured in order to implement and maintain an effective system.
The certificate course is dedicated to the following topics, among others:
- ISO 14971
- General basic safety and performance requirements according to EU-MDR, appendix
- Post Market Clinical Follow-up (PMCF) – market observation
- PMS and trending
- Risk analysis - risk management plan, report and file
- Identification and traceability
- Practical examples of risk management, risk analysis and assessments
Start is March 15; a total of five full-day seminars are attended.
Participants from Baden-Württemberg have the opportunity to save 50% of the course costs with the support program for specialist courses.
