08:30 - 16:30
Meeting room VIA
2- days Design Control:
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.
We recommend this course for professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.
At the end of the course, you will receive a certificate.
Instruction is targeted towards professionals who are involved in the following areas:
- The development of medical devices
- Quality assurance
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 framework
- 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
MedicalDeviceHQ uses a mixture of lectures, quizzes and practical exercises and the course is evaluated both during and after to maximise the results. The course runs from 09:00 to 16:30.
Maximum participants: 20
Cost for 2 days Design Control training:
- Member of Norway Health Tech: NOK 8300
- Non-member of Norway Health Tech: NOK 11 000
2-Day Project Management Add-on: Learn more about project management for development of medical devices!
Peter Sebelius is holding a unique 2-day add-on course at Norway Health Tech for those who are in the process of product development of medical devices. This is a high-level course which provides tools and techniques to successfully complete a medical device product development project.
Who should attend?
- Project managers
- R&D engineers wanting to become project managers
- Managers working directly or indirectly with projects and product development
Please note, you have to have completed the 2-day Design Control Course by Peter Sebelius to attend this course.
Goal and course content
The learning goals for this course are to:
- Advance your ability to successfully initiate, plan, execute, control and close a medical device product development project
- Increase your ability to finish projects on time and within the budget by using pragmatic methods, tools and techniques provided
- Increase your knowledge on the most common pitfalls in medical device project management and how to avoid them
The two additional days will cover topics such as:
- Defining scope of the project
- Work breakdown structure
- Scheduling and how to not miss deadlines
- Critical path
- Estimating costs and budget
- Resource planning
- Following up on the project’s progress
- Closing the project
MedicalDeviceHQ uses a in interactive combination of lectures, quizzes and practical exercises during the course. To ensure the best results, the course is evaluated both during and when it is completed. The course runs from 09:00 to 16:30.
Maximum participants: 15
Cost for 2-day Project Management training:
- Member of Norway Health Tech: NOK 8700
- Non-member of Norway Health Tech: NOK 13 500
Register on the link and choose if you want 2 days Design Control, 2 days Project Management (requires that you have previously attended the Design Control training) or the full 4 day training.
NOTE: When you register, you are committed and will be invoiced accordingly. If you do not show up you will be invoiced. If you are unable to attend, please let us know AS SOON AS POSSIBLE as there is most likely someone waiting in line to take the spot. Members of Norway Health Tech will be prioritized.Påmelding