White Paper Category: Biocompatibility

One of the most important safety tests for blood-contacting medical devices is hemocompatibility. Hemocompatibility ensures that a device does not cause red blood cell destruction through hemolysis, cause clotting that […]

In the current climate in the United States and around the world, there are a significant number of companies who previously made commercial goods who are now joining the call […]

By definition, a wound is an injury to a living tissue, but most commonly skin.  These wounds can be ulcerative, caused by a burn, or be full thickness due to […]

ISO 10993-1 was revised in August of 2018 and included a big expansion on the risk based development and safety evaluation of medical devices.  There were not a lot of […]

ISO 10993-1 was revised in August of 2018 and greatly expands upon the concepts of bringing risk management into medical device development and manufacturing. Most ISO 10993 documents related to […]

This white paper examines the interpretation of the ISO 10993 guidelines for sub-acute, sub-chronic, and chronic systemic toxicity testing of medical devices. It suggests study designs from the pharmaceutical industry […]

Biocompatibility testing is an essential part of receiving regulatory approval for medical devices. While the testing itself is important, the correct preparation of samples used for testing is equally as […]

This white paper proposes a test method that addresses FDA expectations, practical considerations, and inherent limitations of the canine thrombogenicity test. It discusses the history of the test, considerations when […]

Contemporary regulations surrounding natural products have grown in scope and complexity, as both regulatory agencies and consumers demand assurances that ‘natural’ medical products in the market are safe. With these considerations […]