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.
CMR & ED Testing for EU Medical Device Regulation (EU MDR) This application note covers a subset of EU MDR changes and describes screening of medical devices or medical device components for two specific families of compounds, namely diisocyanates and phthalates.
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).