Gradient

Trends Newsletter | Fall 2022

Medical Device Safety Assessment Overview

Fall 2022 | Medical Device Safety | by Joel M. Cohen, Sc.D., DABT

Medical Device Safety Assessment Overview

Increasing demand for a range of medical devices and an evolving regulatory landscape pose new challenges in device testing and highlight a need for more efficient safety and risk assessment methods.

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Skin Sensitization Potential of Medical Devices

Fall 2022 | Medical Device Safety | by Rebecca C. Ticknor, M.S.

Skin Sensitization Potential of Medical Devices

New methods of skin sensitization testing that could eventually offer alternatives to those currently in use continue to progress despite a potentially long road to regulatory acceptance in the US.

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New Developments in Medical Device Chemical Characterization

Fall 2022 | Medical Device Safety | by Lindsey K. Borton, M.P.H.

New Developments in Medical Device Chemical Characterization

Strict new requirements for evaluating medical device safety highlight the importance of comprehensive chemical characterization.

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The Evolving Regulatory Landscape for Medical Device Biocompatibility

Fall 2022 | Medical Device Safety | by Bill Wustenberg, D.V.M.

The Evolving Regulatory Landscape for Medical Device Biocompatibility

A recent increase in medical device recalls has fueled scrutiny of current safety assessment methods, which has motivated reduced reliance on a presumption of safety based on predicate devices and increased data and device testing requirements.

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What's New at Gradient

Fall 2022 | Medical Device Safety | by Gradient

What's New at Gradient

A listing of awards, announcements, recent publications and upcoming presentations.

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