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Regulatory Requirements for Medical Devices

A required course in the Certificate Programs in Medical Device Development, Clinical Trials: Medical Device and Drug Development, and Regulatory Affairs and Compliance.

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

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.

NOTE: This course utilizes Zoom for weekly live online synchronous meetings. The sessions will be recorded and posted for students who are not able to attend, watching the recording is mandatory. The Zoom meeting link and password to join will be provided in your course. A device with audio and visual will be needed to participate. The following student guide provides additional resources/information on how to use and access your courses Zoom sessions.

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  • Details
  • $735
  • September 19, 2022 to November 27, 2022
  • Delivery Mode: Online
  • Reg#: 00144
  • ID/Units: EECS X445.2  (3.00)
    ( Section 1 )
  • Quarter: FALL 2022

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.

Dan Modi, M.B.A., RAC, has 25+ years’ experience in Standards Certification, Regulatory Documentation and Design Control requirements for medical devices. Modi is certified as RAC (Regulatory Affairs Certification), NCE (NARTE Certified Engineer) and CQA (Certified Quality Auditor through the American Society for Quality-ASQ). He was Director of Regulatory Certification, responsible for Design Quality and Regulatory Certification at Alcon Research Ltd., a division of Novartis. He has wide experience working with simple to complex electro-medical products and in supporting small start-ups to fortune 500 companies over the years.

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
START09/19/2022Monday------Online (Access Begins)---
OL-LEC10/11/2022Tuesday7:00 PM8:00 PMZoom---
OL-LEC10/18/2022Tuesday7:00 PM8:00 PMZoom---
END11/27/2022Sunday------Online (Access Ends)---