Biocompatibility

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