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

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