Project Management for Product Development of Medical Devices (ENG) (4 day)
Project management for product development of medical devices
This 4 day course provides a high level overview for developing a medical device as well as the tools and techniques for project delivery.
The course has an integrated approach to project management and is suitable for a range of different job roles within the medical device sector. Topics include:
- How to define requirements
- Which requirements must be met to CE mark a product
- Where risk analysis and usability should be introduced into a product development project.
- Information on laws and regulations from CE Marking, risk management (ISO 14971), usability (EN 62366), software lifecycle processes (EN62304 and other standards are referenced within the course.
All the subject matter of the design control course is also included within this course