Masterclass Certificate in Practical Biocompatibility Applications
-- ViewingNowThe Masterclass Certificate in Practical Biocompatibility Applications is a comprehensive course designed to equip learners with essential skills in biocompatibility applications. This certification program focuses on the importance of ensuring medical devices and other products are safe for human use, by understanding and testing for biocompatibility.
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โข Introduction to Biocompatibility: Fundamentals of biocompatibility, regulatory framework, and key concepts.
โข Biological Responses to Medical Devices: Cellular and tissue responses, inflammation, and foreign body reactions.
โข Cytotoxicity, Sensitization, and Irritation Tests: In vitro and in vivo testing methods, OECD guidelines.
โข Systemic Toxicity and Genotoxicity Evaluation: In vivo and in vitro tests, regulatory requirements.
โข Material Mediated Pyrogen Testing: Limulus amebocyte lysate (LAL) assay, monocyte activation test, and regulatory aspects.
โข Hemocompatibility Assessments: Hemolysis, platelet activation, and coagulation assays.
โข Implantable Device Testing: Implantation studies, biodegradation, and ethical considerations.
โข Biocompatibility Standards and Guidance Documents: ISO 10993 series, FDA guidance, and international regulations.
โข Risk Assessment and Management in Biocompatibility: Hazard identification, risk analysis, and mitigation strategies.
โข Case Studies on Biocompatibility Applications: Real-world examples, best practices, and lessons learned.
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