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Medical Device Life-Cycle Management

A required course in the Certificate Program in Medical Product Development.

Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.×

Course Description

From concept through development to approval, the Medical Device Life Cycle integrates design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Device Life Cycle in order to manage projects and multifunctional teams. Topics covered include Product Development Process, Customer Requirements, Proof of Concept, Design Control, Design Verification and Validation, Design Transfer, Product Launch, Risk Management, regulatory strategy, intellectual property management, project management, start-up company experiences, and time to market.

Recommended prerequisite: EECS_X445.2, Regulatory Requirements for Medical Devices or equivalent experience.

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  • Details
  • $725
  • March 29, 2021 to June 06, 2021
  • Delivery Mode: Online
  • Reg#: 00115
  • ID/Units: BME X408  (3.00)
    ( Section 1 )
  • Quarter: SPRING 2021

Instructor


Dr. Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.

Catherine A. Kusnick, MD is a UCI medical school graduate and Principal, Headlands Consulting. She has headed clinical departments at medical device start-ups for 8 years after 2 years in pharma. She currently consults with device start-up companies. Her strategic and tactical experience includes study conduct, project management, data analysis, Medical Affairs, writing Regulatory submissions. While practicing medicine, she taught at two medical schools, served as a Study Investigator and published/lectured extensively.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START03/29/2021Monday------Online (Access Begins)---
END06/06/2021Sunday------Online (Access Ends)---