Description

This course is a sequel to Medical Device Development, but can also be taken by those who have more than one year experience as a medical device engineer or other professionals. Material in this course picks up from the point of “design freeze” and discusses the events occurring from then on through obsolescence. Those in the device industry understand that development does not cease once a product is released to market: there are numerous tasks required to keep the device selling in a heavily regulated environment. Aspects of managing devices covered in this course include: Manufacturing process development and validation, Regulatory systems outside the United States, Clinical trial practices, and Product Management. The course is 100% online and modeled after the “Advanced Medical Device Development” class taught at the New Jersey Institute of Technology since 2013. It is designed to give a “big picture” view of devices and how their development and life cycle proceeds. Anyone specializing in a particular area, such as Quality or Regulatory, can gain good understanding of their own area as well as others that touch the process.

Advanced Medical Device Development Course Objectives:

Understand the processes for medical device development after “design freeze”
Become familiar with the European regulatory framework for medical devices
Gain an understanding of manufacturing process validation
Build on the student’s current understanding of the Quality Management System
Understand key aspects of Product Management both during and after product launch
Discuss Good Clinical Practices and regulations surrounding management of clinical trials
Who should take this course?

Engineers with some basic medical device design experience
Anyone who needs an early primer on medical device manufacturing process development
Students interested in pursuing medical device development
Physicians and Professors with device ideas that need instruction on how to get there
Medical device project team members that need basic primers on clinical and regulatory practices
Advanced Medical Device Development Course Outline:

Technical File – FDA vs. Foreign Regulatory
DHF, Design Specification, Design Verification & Validation
Design Transfer – DMR, DHR, SOP’s; Design Changes – Engineering Change Orders
Process Design and Development, Process Risk Management, IQ/OQ/PQ
Product Management and Product Lifecycle
Quality System Regulation & Good Manufacturing Practice – Part 1
Quality System Regulation & Good Manufacturing Practice – Part 2
Clinical Trial Management and Regulation
What you get:

Unlimited time access to 28 recorded online lectures (~ 5.5 hrs of content)
Basic template documents for common manufacturing process validations
A 50-page e-book in PDF format summarizing the regulations necessary for Good Clinical Practices. See detailed description of e-book at Clinical Research Certification Notes.
Access to a forum for discussing/asking questions to the instructor
Free updates to course material