Course objective and outcome
The course is focused on how to manage the development process for new medical devices and maintaining them in an organization where design control requirements apply.
 
The course combines several of the key project management tools with the design control process. This gives you a unique opportunity to know how to manage development projects in the medical device business and at the same time get a detailed knowledge of the different design control documents required by the authorities.
One of the challenging issues for all development projects in the medical device industry is how to manage all the different stakeholders and project team members in a very regulated area. The course introduces a unique tool for ensuring a sufficient maturity of the device development and at the same time ensure the necessary progress of the project.
 
Content
The learning goals of the course:

• How do you organize your project, preparation of the project plan, identification of key stakeholders and how to manage the stakeholders and project teams
• Learn how to identify and handle project risks throughout the project
• Method for ensuring the project progress and how you ensure the necessary focus from your project team
• Provide pragmatic methods, tools and techniques which will boost the ability to be efficient in the development of medical devices and the related documentation
• Improve understanding of how and why design control requirements should be implemented
• Using the development stage-gate-model as a tool for ensuring the development maturity during the development process
• Increase knowledge on the most common pitfalls in medical device product development and how to avoid them

The course comprises lectures and interactive workshops. The trainer will follow up on learning objectives throughout the course. This means that you will have to answer questions on the topics covered to ensure that the objectives are met.
 
Who should attend

• R&D engineers wanting to become project managers
• Consultants working with medical device projects and design control
• 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

 Recommended minimum pre-requisites for this course are any or all of the following:

• Experience with product development in a regulated industry
• Experience from working in project organization, or with ISO 13485/21 CFR 820

Trainer
Søren Lyngsø-Petersen, CEO, Pharma4ever QA ApS
 

"I gained in-depth knowledge about a number of topics as well as a great overview of the development process. It was concrete and not just theoretical so I could apply it directly to my day to day job. I feel confident that this course will strengthen me in performing my job with high quality. The teacher was very professional and you could tell that he had a lot of experience. Also, there was a great balance between exercises and presentation to make sure to keep you up to speed" 

"Experienced teacher"

"I liked the overall setup of the course. The way the material was presented and the examples giving along the way"

"The instructor had a good way of communicating, and involved the participants during the course. It went through the areas that i felt I needed covered"

"Very well prepared course and experienced instructor. Good facilitation"

Participants, Fall 2021