Course Description

Project Management of Medical Device Development

Course Description:

Based on proven Project Management Body of Knowledge methodology and ideas (Project Management Institute), this course gives an overview of the project manager’s responsibilities throughout the product development process. The course primarily guides the learner through the processes of project management taking into account the complexity of technical issues and the multitude of regulatory requirements during the development of a medical device while providing valuable information and guidance on how to detect critical paths and have contingency plans ready to optimize efficiency in the development process.

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Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • prioritize the project manager’s responsibilities in medical device development,
  • implement the correct procedures that will facilitate the project manager’s fulfillment of his/her responsibilities,
  • successfully maneuver the medical device specific considerations in your medical device development project management plan.

Who Should Enroll:

Development engineers, development project managers, quality managers, regulatory affairs managers, clinical research managers who liaise closely with R&D, medical device manufacturer executives.

Prerequisite Knowledge/Requirements:

Participants should have about 3 years of practical involvement in medical device development. This course requires multidisciplinary practical knowledge in the fields covered by the following courses:

  • ID 71 - Applied Project Management
  • ID 158 - Introduction to Medical Devices from Idea to Market: 12 Course Suite
  • ID 183 - The Design, Development and Industrialization of Medical Devices
  • ID 154 - Role of RA Specialist in the Design Process
  • ID 77 - Risk Management for Medical Devices in the EU and US
  • ID 196 - ISO 13485: Foundation and Basic Principles
  • ID 185 - Importance of Technical Standards in the Medical Device Sector

Subject Matter Expert:
Steve Marshall

85 min

Release date:

Related resources:

Case studies:

Peer review:
Michael Maier

Basic Account: € 340.00
Premium Account: € 255.00

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