According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it comes in contact with the patient. The standard provides a […]

Medical Device biocompatibility, once considered just a "box-checking" activity, continues to become more complex. This was the focus of a talk at the 2012 American College of Toxicology Annual Meeting […]

This year has been somewhat up and down for medical device developers. The medical device excise tax was approved, and any devices sold starting in 2013 will be subject to […]

Increasingly, device makers are discovering what pharmaceutical companies have known for many years – that using CROs to support regulatory testing can speed up development efforts and, ultimately, save money. The […]

Have no fear! You can access it here in recorded format or as a slide presentation. To provide more information on reusable device validations, Pacific BioLabs conducted a webinar on reusable […]

If you work for a medical device or pharmaceutical company that is not using gamma irradiation to sterilize your products, this is something you may want to consider. Gamma rays, a […]

With one of the fastest areas of growth for plastics being the Medical Device Industry, there has been an increased demand for biocompatibility testing.  One aspect of evaluating whether a […]

Biocompatibility testing measures how compatible a device or material is with a biological system, and is needed to begin human trials of a medical device. Biocompatibility testing can provide an […]

Until recently, the only methods available to measure cytotoxicity were qualitative ones. These methods are subjective and rely on the skill of a microbiologist to identify malformed or lysed cells. […]

*The following article is the Executive Summary from the booklet "Assessing Biocompatibility: A Guide for Medical Device Manufacturers" Purpose of Biocompatibility Testing Biocompatibility is, by definition, a measurement of how compatible a […]