Project Management of Medical Device Development
This course provides an overview of the project manager’s responsibilities in the product development process. It is based on the Project Management Institute’s body of knowledge and methodology.
The course reviews the project management process, taking into account the complexity of technical issues and the multitude of regulatory requirements which occur during medical device development. It also provides valuable insight into how to detect critical paths and prepare contingency plans to optimize efficiency in the development process.
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Upon successfully completing this course, trainees will be able to:
- Prioritize the project manager’s responsibilities during the development process
- Implement the proper procedures to help facilitate the project manager’s responsibilities
- Identify the specific considerations for medical device development project management plans
Developmental engineers and project managers, quality and regulatory affairs managers, clinical research managers who work closely with R&D, and medical device manufacturer executives are all encouraged to enroll in this course.
Participants should have approximately three years of practical involvement in medical device development.
The following courses are required:
- Applied Project Management courses
- Introduction to Medical Devices from Idea to Market courses
- The Design, Development and Industrialization of Medical Devices (ID 183) – Under construction
- Role of RA Specialist in the Design Process (ID 154)
- Risk Management for Medical Devices in the EU and US courses
- ISO 13485: Foundation and Basic Principles (ID 196)
- Importance of Technical Standards in the Medical Device Sector (ID 185)