Biological Evaluation of Medical Devices This application note answers some frequently asked biological evaluation questions, including: How Do I Address Biological Risk in My Medical Device? If My Manufacturing Process Changed, Do I Need to Redo My Biocompatibility Testing? Should I Prepare the Biological Evaluation Plan (BEP) In-House or Use a Consultant?
Chemical Characterization of Medical Devices: Seismic Shifts in ISO10993-18:2020 January 2020 brought a new and transformative revision of ISO 10993-18, the principle standard governing chemical characterization of medical devices. Coming 15 years since the last published revision, the standard dramatically transforms the scope of the chemical characterization workflow.
Material Science in ISO 10993-18 Testing This application note discusses some of the complexities of ISO 10993-18, and how an understanding of material science plays an important role in data interpretation.
Profiling Scotch Whisky CPG uses Gas Chromatography-Mass Spectrometry (GC-MS) and Head Space Gas Chromatography (HS-GC-MS) to profile a small selection of malt whisky samples from various regions of Scotland and aged over a range of years in casks (or multiple casks).