The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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...
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.
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...
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...
