This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design control requirements apply. The course covers both European and US requirements.
The course is focused on how to develop new medical devices and maintaining them in an organisation where design control requirements apply. The course addresses what level of documentation is required and provides tools on how to work successfully and efficiently with design control. Since standards play a significant role in design control and development of medical devices, the course will reference the most commonly used standards that apply to medical devices. This includes ISO 14971 on risk management, and IEC 62366 on usability engineering. The participants will also learn about the most common pitfalls in medical device product development. It covers both US and EU requirements. The course employs a lean and pragmatic approach to medical device design.
All the contents of this course are included in the project management for product development of medical devices course.
Who should attend?
Instruction is targeted towards professionals who are involved in the following areas:
- the development of medical devices
- quality assurance
There are no pre-requisites, but it is helpful to have experience from product development in medical device industry or any other regulated industry or experience from the medical device industry in general.
The learning is:
- to provide pragmatic methods, tools and techniques which will boost the ability to be efficient in the development of medical devices.
- to improve understanding of how and why design control requirements should be implemented.
- to increase knowledge on the most common pitfalls in medical device product development and how to avoid them.
The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificates.
The course will be conducted in English.
Peter Sebelius, Gantus AB
"Realy liked the instructor's thoroughness and the way the course was built was a very positive experience. The query rounds along the way were a good indicator of whether one had paid full attention along the way"
"The inspiring and engaged teacher managed to cover all relevant topics at a proper level"
"A energic and enthusiastic cource leader"
"Very effecient and competent teacher"
"Really like the pragmatic examples and critical perspectices"
Participants, Fall 2018