Project Management for Medical Devices

Project management for Medical Devices Course

This is a basic online course about how to manage medical device projects for new professionals or those just  entering the field.  Courses in Project Management (PM) abound both in the classroom and online. However, nearly all currently available courses focus either on generic PM or specific industries such as construction and software development. There is a decided lack of PM courses that address medical device development (MDD). Enter this course.

Through a series of video lectures and slides, this course will tackle the combination of best practices in PM and design controls for MDD. Students will understand how the contemporary MDD process (design controls) fits into the accepted method for PM taught by the Project Management Institute.

After a brief definition of PM and medical devices, the course will step through the accepted PM Processes and apply them to the equivalent steps taken in Design Controls as per regulation 21 CFR 820.30, which governs medical devices. Next, the course will describe key PM Knowledge Areas appropriate for MDD and introduce some new ones, such as Regulatory.

Medical device professionals dealing with development projects either directly or indirectly can benefit from this course, as well as newly hired engineers and project managers that need a basic introduction to the field.The course is 100% online and modeled after the “Systems Management for Medical devices”  class taught at the New Jersey Institute of Technology since 2009.  (It was formerly called Project Management for Medical Devices.) Students in this course will gain a broad  overview of all aspects for the early phases of device design.  This course assumes no prior knowledge of  medical devices or their development.  New students should be able to understand the entire content with  no prior background.

 

Project Management for Medical Devices Course Objectives:

  • Function as a member of a medical device project team
  • Understand how to further the student’s education on Project Management
  • Relate concepts of Project Management to Medical Device Development

Who should take this course?

  • Engineers working on medical device projects
  • Product development professionals that work with medical device development
  • Newly hired medical device company professionals that need information on project management
  • Graduate and Undergraduate students whose schools do not offer courses like this one

Project Management for Medical Devices Course Outline:

Section 1 – Introduction

  • Introduction – Course Details
  • Basic Medical Device and Project Management Terms
  • Considerations for Regulatory in Project Management
  • Medical Devices in the Context of Project Management
  • Influence of Organizational Structure and Type on Project Management

Section 2 – Project Management Processes

  • Project Initiation – The First Project Management Process
  • Project Planning – Integration with Design Controls and Medical Device Development
  • Project Planning – Planning Tools
  • Project Execution
  • Project Monitoring & Controlling
  • Project Closing

Section 3 – Project Management Knowledge Areas

  • Project Management Knowledge Areas – Introduction
  • Project Management Knowledge Areas – Scope Management
  • Project Management Knowledge Areas – Time Management
  • Project Management Knowledge Areas – Cost Management
  • Project Management Knowledge Areas – Risk Management
  • Project Management Knowledge Areas – Project Quality Management
  • Project Management Knowledge Areas – Procurement Management
  • Project Management Knowledge Areas – Human Resources Management
  • Project Management Knowledge Areas – Communication Management
  • Project Management Knowledge Areas – Integration Management

Section 4 – Project Management Application & Example – A Clinical Trial

  • Project Management Application – Intro to Clinical Trials

What you get:

  • Unlimited time access to 27 recorded online lectures (~ 8 hrs of content)
  • Unlimited time access to mini-simulation learning tool
  • Access to a medical device forum for discussing/asking questions to the instructor
  • Free updates to course material

6 thoughts on “Project Management for Medical Devices

  1. Profile photo of rabrams001 rabrams001 says:

    Hi.. could you advise on the proper sequence between the following courses: advanced medical devices and project management, medical devices?

    Next month I will lead a new project from start to finish. I’ve been in the medical industry for 10 years and never acted as project manager for a full project. I have some project management experience in other industries and for subsets of medical projects.

    1. Profile photo of Josh Josh says:

      They can be taken in either order because they cover different aspects. Advanced Medical Device Development covers the sequence of medical device development from design freeze to post-market, without actually going over project management aspects in detail, such as scheduling, planning, costing, etc. On the other hand, Project Management for Medical Devices covers just that, but does not emphasis which part of the medical device development process is taking place.

      You could take one without the other, especially in your case with prior experience.

  2. Profile photo of rabrams001 rabrams001 says:

    Thanks for the response. Unfortunately, I may not have clearly posed my question. I just started a new position as project manager for a new medical device. Which course (assuming my company will pay for only one) should i sign up for: “Project Management for Medical Devices” or “Advanced Medical Device Development”? I have 10 years experience in medical device development and I have some generic project management experience to support non-medical device releases.

  3. Profile photo of Josh Josh says:

    Project Management for Medical Devices

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