Why it is useful
A risk management plan is required because an organized approach is essential for effective risk management, the plan provides the roadmap for risk management, encourages objectivity and helps prevent essential elements being forgotten.
How to use it
1. If you are developing a brand-new product, establish as much as possible of this plan in the planning phase of your project.
2. If you are making a revision of an old product, or adding a product to a range that this plan applies to, the plan might only have to be updated slightly.
3. Note that the plan shall be maintained, that is, it should reflect what you are doing and the other way around.
Need risk management training and a course certificate?
Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. Created by industry experts. Certification on successful completion of course.