On-Demand Catalog

All sessions average between 60 and 90 minutes.

Overview of Medical Device Law and Regulation
International Issues for Medical Device Manufacturers: An Introduction
Regulatory Requirements for Medical Device Manufacturing and Quality System Regulation: An Introduction
Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments
An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests
Biologics License Applications (BLA): An Introduction
An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars
The Regulation of Biological Product Manufacturing: An Introduction
Post-Approval Pharmacovigilance of Biological Products: An Introduction
An Introduction to Biosimilar Product Regulation and Approval

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