On-Demand Catalog

All sessions average between 60 and 90 minutes.

An Introduction to the Regulation of Promotion and Advertising for Medical Devices
FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices
International Issues for Medical Device Manufacturers: An Introduction
Regulatory Requirements for Medical Device Manufacturing and Quality System Regulation: An Introduction
An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Post Marketing Issues for Medical Devices: An Introduction
Medical Device Clinical Investigations: An Introduction to Sponsor Responsibilities and Compliance Issues
Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction
Overview of Medical Device Law and Regulation
Medical Device Clinical Investigations: An Introduction to Investigational Device Exemptions (IDEs), Institutional Review Boards (IRBs) and Informed Consent

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