REF. GR02 – INTRA / INTER
MANAGING RISKS
COURSE DESCRIPTION
This training will allow you to update or acquire practical knowledge to identify and manage risks related to the use of medical devices in accordance with the recommendations set out in ISO 14971:2019
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Identify what is new in the 2019 version compared to the 2012 version
- Become familiar with the risk management methodology described in the standard
- Raise the awareness of all parties involved to ensure effective risk management
TARGET TRAINEES
MD manufacturers, and more particularly:
- Quality/Regulatory Affairs Manager
- R&D team
- Manufacturing Manager
- Product Leader
- Sales Representative
- Technical Director
PREREQUISITES
- General knowledge of the regulatory framework for MDs and/or IVDMDs
- Some knowledge of risk management (EN ISO 14971 version 2012)
- Some knowledge of CE marking requirements in terms of Technical Documentation
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Tailored examples – group exercises
- Reference to Regulation (UE ) 2017/745 and EN ISO 14971
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Presentation of the course objectives and method to ensure that they are achieved:
- Regulatory requirements: a review
- ISO 14971:2012 compared to ISO 14971:2019
- General risk management principles according to EN ISO 14971
- Scope
- Definitions
- Risk management process
- Personnel skills
- Risk management plan
- Risk analysis – Evaluation – Control
- Overall residual risk
- “Production and Post-Production” activities
- Summary/Q&A
- Course evaluation and conclusion
Virtual classroom training: the course can be divided into two half-days.
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
