Project management for product development and medical devices

This course focuses on project management, but includes references to terms, standards,
tools, and techniques from product development and the medical device industry. In addition
to project management, the course covers, among other things, how requirements may
be documented, what requirements must be met in order to CE mark a product and where risk
analysis and usability should be introduced into a product development project.

The course can be customized and combined to fit your organization’s needs. You can, for example, let the course run parallell with a real project, split it into several course occasions or add a special perspective to the course, such as: how to work with project management as a consultant or contract manufacturer.

Purpose and Learning Goal

The learning goal for the course is for the participants to acquire the basic knowledge and skills necessary to initiate, plan, execute, control and monitor, and close‐out a medical device product development project.

Instruction is targeted towards professionals who are involved in the following areas: the development of medical devices, meeting design control requirements (such as those in quality assurance), project management, design engineering, and members of research and development
or new product development teams. Recommended minimum prerequisites for this course are any or all of the following: experience with product development projects in a regulated industry, experience working in project organization, or with ISO 13485/21 CFR 820.

"The course held a very high quality with a good balance between lectures and workshops. The course both covered a large area and went into depth as well as left room for many interesting discussions. These four very intense days have provided a me with a good foundation."

Maria Brisslert, Vitrolife

"The course covers the existing need for project management in medical device projects. The lecturer was very enthusing. I will recommend this course to my colleagues."

Björn Nordenström, Maquet Critical Care

"The course gave me knowledge and understanding of what it means to lead and participate in a development project for a medical device. The lecturer was able to transfer theories and processes into practical examples in a both enthusiastic, understandable and competent way. Throughout the course theory was mixed with reality based exercises, which gave the course an extra dimension. I definitely recommend this course."

Kristian Bladh, Scalae

• Course binder
• The book "A Guide to the Project Management Body of Knowledge"
• Handouts of PowerPoint slides
• Document templates
• Course certificate (active participation in at least 80% of the of the scheduled course time is required) 

Day 1, 09:00-17:30

• Project management
• Project models
• Laws standards and regulations
• Key elements of design control
• The project model of the course
• Initiating phase
• Create project charter
• Identify stakeholders

Day 2, 08:30-17:30

• Planning phase
• Collecting requirements
• Defining scope
• System design
• Product risk management
• Plan verification and validation
• Create WBS
• Scheduling
• Develop human resource plan
• Project risk management

Day 3, 08:30-17:30

• Planning phase (continued)
• Estimate cost
• Develop project management plan
• Design review
• System decomposition phase
• Executing phase
• Execute, control and change

Day 4, 08:30-16:00

• Executing phase (continued)
• Control schedule
• Control scope
• Control cost
• Monitor risk
• Design transfer
• Verify scope and VVQ
• Closing phase
• Project close-out
• Repetition

The fee for the course is 20,900 SEK including lunch and course material (excl. VAT and living
expenses).