GPC/SEC Analysis of PLGA Used for Drug Delivery
Summary Poly(lactide-co-glycolide) (PLGA) has emerged as a versatile polymer in the medical device industry, primarily due to its highly tunable degradation rate, varying from months to years. This tunability allows PLGA to be used in various applications, with particular interest in drug delivery systems. While the degradation rate is tied to the block copolymer’s chemical […]
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. View PDF
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. View PDF
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. View PDF
Central venous catheter with guide wire,plastic sheat, needle and syringe
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? View Full PDF View Short Version