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Author: Sarah Campbell





April 7, 2022

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...

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January 18, 2018

What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap

Toxicologists offer their perspectives on the future of testing. FDA recently published its Predictive Toxicology Roadmap to enable the adoption of advances in toxicity testing. While this announcement from FDA may not have any immediate effects on the toxicology testing...

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January 4, 2018

ANSI/AAMI PB70: Closing the Gap

Comments from a recent AAMI meeting on revising ANSI/AAMI PB70:2012 “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities” reveal what changes could be in store for the standard. Read Full Story

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September 8, 2016

How Chemical Characterization Can Supplement and Support Biocompatibility Testing

Download this whitepaper to examine the various ways in which chemical characterization can augment and refine the biocompatibility testing process. Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about...

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January 29, 2016

New FDA Guidance on Gowns Intended for Use in Health Care Settings

FDA recently released an updated guidance document to clarify regulatory requirements for gowns. This new guidance impacts manufacturers that currently sell gowns as well as manufacturers that intend to market gowns in the future. The guidance clarifies what types of...

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