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.
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. In addition to project management, the course covers (among other things) design control requirements, risk management and ISO 14971, software lifecycle processes EN 62304, usability engineering EN 62366 and auditing. In short, it is design control in a project management context. The course covers both US and EU requirements.
Concept and definitions for project management are harmonised with "A Guide to the Project Management Body of Knowledge" (authored by PMI, Project Management Institute) which means that the course is suitable if you intend to be certified as project manager (PMP). The course is equivalent to about 30 PDU´s (Category B).
Who should attend?
This course is targeted towards professionals involved in:
- Project management
- Development of medical devices
- Meeting design control requirements (such as those in quality assurance)
- Design engineering
- Members of research and development or new product development teams
The course is particularly beneficial to those about to become or who are recently appointed projects managers. The course is also appropriate for more experienced project managers new to the medical device industry.
The learning goal for the course is for participants to acquire the basic knowledge and skills necessary to initiate, plan, execute, control, monitor and close-out a medical device development project.
The course will be conducted in English.
The course consists of a mixture of lectures, workshops and discussions. The instructor will follow up on learning objectives throughout the course, meaning that participants continuously 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 certificate.
Peter Sebelius, Gantus AB
"This is the best course I have ever been on. I have recommended, that it should be compulsory for all project managers in my company"
Participant, Autumn 2013