Usability is an integral part of medical device development. Thus, it is important to understand how users may interact with a device, in order to ensure proper function and avoid safety issues.
To reduce the risk of use errors, the Medical Device Regulation (MDR) requires that medical devices be designed with specific focus on the characteristics of the intended users. The IEC 62366-1 standard describes the various activities that should be implemented in a usability engineering process to fulfill the requirements of the MDR.
- IEC 62366-1:2015 – History and regulatory context
- Usability – terminology and definitions
- The usability engineering process – step by step
- Formal usability validation
- Legacy devices
This course is intended for personnel involved in medical device development, including quality and regulatory professionals.
After the course, participants will know what is required, from a regulatory perspective, to ensure good usability for a medical device. After a successfully completed course, participants will receive a certificate.
Recommended prior knowledge
The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.
Course material will be in English, verbal presentation and discussions in Swedish or in English, depending on the participants..
Cecilia Emanuelsson, Principal Consultant
Training course / seminars
This course can be modified to reflect your product and company. It can be held at customer site or online.
Price depends on the overall arrangement for your customized course. An offer will be submitted based on your request.
More about our customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.