Project Management for Product Development of Medical Devices

This four day course focuses on project management, and includes references to terms, standards, tools and techniques from product development and the medical device industry.

Introduction 
This project management course provides a high-level overview of the project process for developing a medical device as well as the tools and techniques needed to get through a project. The course has an integrated approach to project management and design control requirements. Topics include what level of documentation is required, how to define requirements, what requirements must be met in order to CE mark a product, how to budget and schedule to avoid cost and schedule overruns. Where risk analysis and usability should be introduced into a product development project are also addressed in the course.

All the contents of the design control course are included in this course.
 
Who should attend?
Instruction is targeted towards:

  • R&D engineers wanting to become project managers
  • consultants working with medical device projects
  • 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 organisation, or with ISO 13485/21 CFR 820

Learning goal
The learning goals are:

  • to advance the ability to successfully initiate, plan, execute, control and close a medical device product development project.
  • to provide pragmatic methods, tools and techniques which will boost the ability to finish projects on time and on budget.
  • to improve understanding of how and why design control requirements should be implemented.
  • to increase knowledge on the most common pitfalls in medical device product development and how to avoid them.

Course form 
The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificates.
 
Course language
The course will be conducted in English.

Instructor
Peter Sebelius, Gantus AB

"Spot on scope, good flow in couse, Engineer minded, workshops, check quistions all the time, good and expirenced teacher"

"The content of the course matches my profile perfectly, the course leader Peter Sebelius was very well prepared and delivered with an extraordínary enthusiasm and insight"

"Spot on scope, good flow in couse, Engineer minded, workshops, check quistions all the time, good and expirenced teacher"

"What I really liked about this course was the instructor"

Participants, 2017-2018

Indtast et "Purchase order number" hvis din virksomhed forlanger det på fakturaen.

Kontakt

Morten Petersen
Uddannelseskonsulent
49184703