TRAINING
Risk Management to meet the IVDR and ISO 14971
Risk Management is one of the cornerstones of European legislation and some of the expectations are unique to Europe. It’s an important tool to ensure that you consistently assess risk between product and at each step in the life cycle on market and post market.
How to prepare for the cultural shift in our industry when the new IVDR is coming up in 2022? The aim of the course is to understand the key concepts of risk management and how to use ISO 14971 to meet the IVDR.
The Risk Management session will be covered to look at it from two directions one from the perspective of the regulation but also from the perspective of the standard as well. Overall you will learn that risk management is not a one-off exercise, it is an on-going process post market. Each time you will have a PMS, you need to consider your risk management assess every time.
Program Overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- Risk Management Basics
- Risk Management Process | Analysis and Evaluation
- Risk Management Process | Control and Benefit: Risk
- How much is enough?
- Final remarks
- Q&A
Learning Objectives
- Understand Risk Management under the IVDR
- How to use ISO 14971 to meet the IVDR
- Risk Management Basics
- ISO 14971 process and the details of the IVDR
- Lessons learnt from IVDR
- Risk Management on-market | Design challenge, Post market surveillance
Who should attend?
- Senior Management
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical Affairs
- R&D, Product Development, Manufacturer, Operations and Marketing Managers
- International registration department
There is no prerequisite for this course but participants will benefit from a basic knowledge of the IVDR in Europe.
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.