Biocompatibility of Medical Devices
Biocompatibility of Medical Devices
If you are involved in the production or supply of medical devices, biomaterials, resins, or other raw materials for medical devices and device-drug combination products, or if you are a biomedical engineer seeking to develop a medical device, the experts at 2SD Toxicology Services offer consulting services to help you prepare-
• Medical device biocompatibility test plan per ISO 10993-1:2018 guidance and US FDA Guidance
• Extractable and leachable testing plan – solvent selection, extraction condition, and AET calculation per ISO 10993-18:2020 guidance
• Toxicological risk assessment of E&L of medical devices per ISO 10993-17:2002
• Biological Safety Evaluation Report
• EU MDR Restricted Substances evaluation
• Material biocompatibility assessment
• Design and manufacturing change assessment
• Biocompatibility study gap assessment
• Biocompatibility study monitoring – including study design and protocol development
• Evaluation of medical device sterilization methods
• Regulatory support for FDA and EU MDR health authorities
• Systematic literature review per ISO 10993-1 Appendix C