Participants will acquire basic knowledge on how to work with product development in an organisation where design control requirements apply.
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 course project management for product development of medical devices.
The course is targeted towards professionals involved in:
Instruction is targeted towards professionals who are involved in the following areas:
· the development of medical devices
· quality assurance
The learning goal is that participants should acquire basic knowledge on how to work with medical device product development in an organisation where design control requirements apply.
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
"The inspiring and engaged teacher managed to cover all relevant topics at a proper level"
"Very effecient and competent teacher"
Participants, Spring 2017