08:30 - 17:00
Online + live virtual
The course is focused on how to develop new medical devices and maintain them in an organisation where design control requirements apply. The course addresses the level of documentation 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. The course covers both US and EU requirements and assumes you work with class II or higher-class products. The course employs a lean approach to medical device design.
The course includes tools and templates on how to implement design control effectively and efficiently.
At the end of the course, you will receive a course certificate for your training records.
Goal and Course Content
The learning goals for this course are to:
- Boost your efficiency in the development of medical devices using the pragmatic methods, tools and techniques provided
- Improve your understanding of how and why design control requirements should be implemented
- Increase your knowledge on the most common pitfalls in medical device product development and how to avoid them
Some of the topics covered are:
- Key terms and project process
- General safety and performance requirements (MDR) and standards
- Risk management and ISO 14971
- Usability engineering
- Design planning, design review and design transfer
- Product approval process
- Change control
- Documentation pitfalls
The blended course format (online + live virtual)
Our state of the art blended courses combine online training with a LIVE virtual classroom session. You get to learn the theory first, at your own pace, during the online course, prior to applying the theory into practice with the guidance of Peter Sebelius, the founder of Medical Device HQ. The online training comprises a number of lessons made up of short pre-recorded videos. You can stop, resume & repeat as often as you want. There are quizzes throughout to check understanding and a final exam at the end.
The classroom session is highly interactive and focuses on applying the theory in practice using case studies and real life scenarios.
Instruction is targeted towards professionals who are involved in the development of medical devices such as:
- Quality assurance
- Project management
- Design engineering
- Product Development team members
Investment for Design Control for Medical Devices training (online + live classroom):
- Member of Norway Health Tech: NOK 6200
- Member of Aleap, Norwegian Smart Care Cluster, The Life Science Cluster, Oslo Cancer Cluster or other cluster/incubators: NOK 7200
- Not a member: NOK 9200
If you want to learn more about project management then please register for the add-on course: Project Management for Product Development of Medical Devices.
Register now – space is limited!Register