Project Management for Product Development of Medical Devices
This four day course focuses on project management, and includes references to terms, standards, tools and techniques from product development and the medical device industry.
This project management course provides a high level overview for developing a medical device as well as the tools and techniques needed to get through a project. The course has an integrated approach to project management and design control requirements. Topics include what level of documentation is required, how to define requirements, what requirements must be met in order to CE mark a product. Where risk analysis and usability should be introduced into a product development project are also addressed in the course.
All the contents of the design control course are included in this course.
Who should attend?
Instruction is targeted towards:
- R&D engineers wanting to become project managers
- consultants working with medical device projects
- project managers from other industries that have moved to the medical device industry
- medical device industry project managers
- managers working directly or indirectly with projects and product development
The learning goal for the course is for participants to should acquire the basic knowledge and skills on how to initiate, plan, execute, control, monitor and close a medical device development project.
The course will be conducted in English.
The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificates. The course is conducted in English.
Peter Sebelius, Gantus AB
"Spot on scope, good flow in couse, Engineer minded, workshops, check quistions all the time, good and expirenced teacher"
"The content of the course matches my profile perfectly, The course leader Peter Sebelius was very well prepared and delivered with an extraordínary enthusiasm and insight"
Participant, Spring 2017