Design control for medical devices
This is a 2 day course focused on how to develop new medical devices and maintain them in organisations where design control requirements apply. The course covers both European and US requirements.
The course addresses documentation requirements and provides tools on how to work successfully and efficiently with Design Control. It references the most commonly used standards such as ISO 14971 on risk management and IEC 62366 on usability engineering.
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.
All of this course is included in our Project Management for product development of medical devices course.
Benefits for you
Overview of the process
Knowing where you are in the process is key to making the right next moves. Many of our students come to the course saying that they looked for the perfect overview, and got it.
Know why and how to work with design control
Design control can be made incredible abstract if the instructor focuses too much on abstract requirements instead of how to actually do the work. The course is very practical in its approach and covers both how to find and interpret requirements as well as how to implement with a lean and pragmatic approach, potentially saving you tons of time
Fun and interactive
We pride ourselves on making a topic that could be considered somewhat “dry” and “boring” interesting and even fun. The course has a high pace with a high level of interactivity.
- The regulatory framework
- Documents and records
- The product approval process
- Audits and Compliance
- Key elements of design control
- Product development phases and design control
- Design planning
- Documentation pitfalls
- Design and development inputs
- Organizational planning
- Design review
- Risk management and EN ISO 14971
- Usability and EN 62366
- Design output
- Design transfer
- Design verification and validation
- Design release
- Change control
Would you prefer a course held on your premises?
We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.
Frequently asked Questions
Register for a course
If you are already prepared to take a course, you can register for one of our upcoming courses using the registration form. You’ll have 24 hours to cancel your reservation in case you can’t come.