Course code RM2
Risk management analysis, using (EN) ISO 14971 (1 day)
This one-day course is designed to provide participants with a broad understanding of the regulatory and reporting requirements of ISO 14971. The basic practice of risk management and risk analysis is considered following the clauses of ISO 14971. Methods for identifying risks, estimating severities and probabilities of occurrence are looked at. Control measures and the monitoring of the effectiveness of such controls are discussed. The relationship of ISO 14971 to ISO 13485 in relation to EU/MDD product regulations is considered, as are the requirements of the FDA/QSR.
Practical examples will be used to demonstrate and discuss these principles
- To provide participants with a broad understanding of the requirements of ISO 14791 as it applies to medical device companies
- To enable participants to interpret the clauses of ISO 14971
- To allow participants to practice the basics of risk management
- To give participants an understanding of risk management planning and the implementation, analysis and monitoring of risk control measures.
- Recognition of the application of ISO 14971 to ISO 13485
Who should attend?
There are no pre-requisites for this course. This course is aimed at:
- Multi-disciplinary Design Team Members
- QA/RA Managers
- QA/RA Staff
- Product and Production Managers
- Management Representative
- Internal Auditors
Participants will receive a comprehensive course manual with reference materials, and a “certificate of attendance” upon successful completion of the course.