Advanced Medical Device Development

 

advanced medical device development course

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 medical device forum for discussing/asking questions to the instructor
  • Free updates to course material

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