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 liked the structure and planning" 

"The trainer presented the course very well and was very knowledgeable. He brought the topic to life with good examples (given both professional & personal insights). Excellent course material & good idea with the "test" on day 1 & 2. Good number of breaks & nice lunch/snacks"

"We've covered the entire course, and the presenter was an excellent instructor who conveyed his knowledge in a very accessible manner. We've had numerous training exercises that provided a solid understanding of the theory"

"Detailed course material for later use"

"This was a great course with an excellent presenter and high-quality materials. The content was presented in a clear and engaging manner, making it easy to grasp complex concepts. Keep up the good work!"

Participants, Fall 2023