In this course, you will learn about key risk management concepts and get an overview of the process steps involved according to the new ISO 14971:2019. You will also learn how risk management practices should be applied throughout a product’s entire life cycle and how it relates to other processes within a quality management system.
We will highlight specific regulatory requirements that apply to risk management and give you an insight into the increased regulatory focus on risk management in the MDR and the IVDR.
With hands-on exercises, group discussions and examples, this course will provide the knowledge and skills you need to understand and perform each step of the risk management process. The practical part of the course includes an overview of the most common tools used for risk analysis, some best practices for documenting results, and how to ensure traceability.
- Requirements according to ISO 14971:2019
- Regulatory requirements according to MDR/IVDR
- Key concepts and definitions
- A walk-through of all process steps
- Methods and tools to support risk analysis
- Elements of risk management plan, report, file and traceability
- Integration of risk management into a product’s life cycle and quality management systems
This course is intended for medical device professionals performing or participating in risk management activities and those who need to learn the basics of risk management and for those who need to refresh their basic knowledge of risk management.
After the course, participants will have a deep understanding of each step of the risk management process and of the methods and tools to support risk analysis.
The participants will be able to do value adding risk management work at their companies.
Recommended prior knowledge
We recommend that participants are familiar with quality systems requirements for medical devices according to ISO 13485.
Course material will be in English, verbal presentation and discussions in Swedish.
Cristina Albu Barkman, Senior Quality and Regulatory Consultant
Maria Rickardsson, Senior Quality and Regulatory Consultant
Dates and location
To be planned
Day 1: 09.00-16.30 (Registration and coffee from kl. 08.45)
Day 2: 09.00-16.00
To be planned
2-day course: SEK 7 400:- for participants from member companies to Swedish Medtech and SEK 9 700:- for non-members.
All prices excl. local VAT.
*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.