Online + virtual training

This course builds on the knowledge already gained on the Design Control for Medical Devices course and focuses on how to efficiently and effectively project manage the development of a medical device. It provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. Information on laws and regulations from CE marking, risk management (ISO 14971), usability (EN 62366) and other standards are referenced within the course.

The course includes tools and templates on how to implement project management effectively and efficiently.

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 on budget using the pragmatic methods, tools and techniques provided
• Increase your knowledge on the most common pitfalls in medical device project management and how to avoid them

Some of the topics covered are:

• The level of documentation that is required
• How to define requirements
• The requirements that must be met to CE mark a product
• How to budget and schedule to avoid cost and schedule overruns
• Risk management and usability engineering.

The blended course format (online + live virtual)

Our state of the art blended courses combine online training with a LIVE virtual classroom session. You get to learn the theory first, at your own pace, during the online course, prior to applying the theory into practice with the guidance of Peter Sebelius, the founder of Medical Device HQ. The online training comprises a number of lessons made up of short pre-recorded videos. You can stop, resume & repeat as often as you want. There are quizzes throughout to check understanding and a final exam at the end.

The classroom session is highly interactive and focuses on applying the theory in practice using case studies and real life scenarios.

Who should attend?

• Project managers within the medical device industry
• R&D engineers wanting to become project managers
• Consultants working with medical device projects
• Managers working directly or indirectly with projects and product development

Investment for Project Management for Development of Medical Devices training (online + live classroom):

• Member of Norway Health Tech: NOK 4000
• Member of Aleap, Norwegian Smart Care Cluster, The Life Science Cluster, Oslo Cancer Cluster or other cluster/incubators: NOK 4800
• Not a member: NOK 6000

Register before Oct 6th – limited spaces available!