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Learn to master a medical device
development project...

Project management for product development of medical devices
Malmö, Sweden 4-7th of May, 2015

The online risk management course is filled with useful knowledge, presented in a pleasant way, but requires your full attention to be able to pass the quizzes and final exam. I have learned many things that I will be able to apply directly in our projects.

Early Bird?
until March 26


Peter Sebelius

Peter Sebelius (PMP) has a vast experience as manager in the medical device industry and is an esteemed project management trainer. Among the many awards that he has received is the Great Design Award and the title “This year’s specialist 2009” by Veckans affärer.

Purpose and learning goal

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


This intense four day project management course includes references to terms, standards, tools, and techniques from product development and the medical device industry. In addition to project management, the course addresses topics like what level of documentation is required, how to define requirements, 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.

Concepts and definitions for project management are harmonized with A Guide to the Project Management Body of Knowledge, which means that the course is suitable if you intend to certify yourself as a project management professional (PMP). The course is equivalent to about 30 PDUs (Category B).

Who should attend

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

Contents at a glance

Below is an overview of some of the topics covered by the course:

Introduction Introduction Planning Execution Closing
Project models Creating a project charter Colecting requirements and defining scope Execute, control and change Close out of a project
Laws standards and regilations Identifying stakeholders System design Control schedule
Design control Plan verification & validation Control scope
Create WBS Control cost

Fees and registration

The course fee is 2,490 € including lunches and course material (excl. VAT and living expenses). When registering before March 26, you will receive an early bird discount of 10% (course fee 2,240 €).

For more information about the course and how to register, visit our website or use contact form. If you want to register for a course, click below button.

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