The comprehensive safety evaluation of medical devices and diagnostics requires an in-depth risk assessment of the composition and materials used. Our in-house team has proven expertise in developing scientific assessments of ingredients for the materials used in the medical devices & Diagnostics (based on classification)
- Biological evaluation Plan: propose the strategy to conduct preclinical studies to meet ISO requirements based on the classification and application of the medical device
- Gap analysis: assess the study reports against the requirements of ISO standards and provide a conclusion on the impact of gaps
- Biocompatibility risk assessment (BRA)/Biological evaluation report (BER): assessment of medical device data, biocompatibility (and other related) studies, and risk assessment of extractables and leachables, as per ISO framework, and provide a conclusion on the safety of the medical device
- Toxicological risk assessment (TRA): risk assessments of extractables/leachables, as per ISO requirements, including conclusion on safety of device