Innovation and Protection

Innovation and Protection

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A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Medical Devices Law and Regulation Answer Book

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Public Health Effectiveness of the FDA 510(k) Clearance Process

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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse

Medical Device Safety

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Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical devic

Regulatory Affairs for Biomaterials and Medical Devices

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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. Thi