In accordance with ISO 10993-1:2018, physical and chemical information for biological risk analysis, formerly referred to as materials characterization, remains the first step in the biological evaluation of medical devices. The extent of physical and chemical information required depends on what is known about the materials of construction, the nature and duration of body contact, and what safety and toxicology data exist. Pace Analytical Life Sciences provides material characterization testing to support our medical device clients by assisting in establishing biocompatibility of a medical device by identifying and quantifying the chemical constituents of the materials. This testing can be used to determine material toxicology, typically following ISO 10993-18 (extractables/leachables) methods.
Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.