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
In co-operation with
9-10 November 2021
Day 1: 09.00-16.30 (Registration and coffee from kl. 08.45)
Day 2: 09.00-16.00
SEK 9 700:- for non-members
SEK 7 400:- for participants from member companies to Swedish Medtech
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
Registration Swedish Medtech | Stockholm
The course is arranged by Swedish Medtech in co-operation with QAdvis.
For reservation see: Swedish Medtech´s kursinformationssida.
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.
QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.