A required course in the Certificate Programs in Medical Product Development, and Clinical Trials: Medical Device and Drug Development, and a prerequisite in the Specialized Studies Program in Regulatory Affairs Management.
Course closed to new registrations:
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Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing premarket notification 510(k), and planning and submitting a Pre-market approval (PMA). Gain knowledge on CE mark according to European Medical Device Regulations 2017/745 (EU-MDR), 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, China and Latin America. Also, enhance your knowledge of related regulatory topics that include: global vigilance requirements and labeling requirements.
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.
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.
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
|Event||Date||Day||Start Time||End Time||Location||Room
|START||03/29/2021||Monday||---||---||Online (Access Begins)||---
|END||06/06/2021||Sunday||---||---||Online (Access Ends)||---