Description of Project management for product development of medical devices
This project management course provides a high level overview 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 meeting 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. 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.
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.
The course is conducted in English
Purpose and learning goal
The learning goal is that participants should acquire basic knowledge and skills on how to initiate, plan, execute, control and monitor, and close a medical device product development project.
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 prerequisites 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.
The regulatory framework
Documents and records
Product approval process
What is enough
Key elements of design control
The project process of the course
Selecting tools and techniques
Develop project charter
Define design and development inputs
System design incl Usability
Plan verification and validation
Create work breakdown structure (WBS)
Develop human resource plan
Project risk management
Estimate cost and Determine budget
Develop project management plan
Direct and manage project execution
Control schedule/Control costs
Monitor and control risk
Design verification and validation
Close project or phase
The course fee is 2,490 € including lunch and course materials (excl. VAT and living expenses). An early bird discount of 10% on the course fee (2,240 €) applies when you register 3 months or earlier before course start.
Gantus ger kurser inom medicinteknik, såsom design control, riskhantering, projektledning för produktutveckling av medicintekniska produkter och kvalitetsledning. Samtliga kurser ges av Peter Sebelius som har mångårig erfarenhet av både utveckling av medicintekniska produkter och att få dem godkända på de...