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.
- Introduction to design control and key terms
- Project process
- The medical device files
- The regulatory framework
- Classifcation and product approval
- Essential requirements, standards and guidelines
- Using standards in medical device product development
- Design and development inputs and traceability
- How to manage requirements
- Risk management and ISO14971
- Usability engineering
- Design planning
- Design review
- Design phase and design output
- Design transfer
- Design verification and validation
- The product approval process
- What is enough?
- Design release
- Change control
- Documentation pitfalls
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.