Masterclass Certificate in Biocompatibility: Regulatory Insights
-- ViewingNowThe Masterclass Certificate in Biocompatibility: Regulatory Insights is a comprehensive course that provides learners with essential skills in biocompatibility and its regulatory frameworks. This course is crucial in an industry where ensuring the safety and compatibility of medical devices with the human body is paramount.
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โข Unit 1: Introduction to Biocompatibility and Regulatory Affairs
โข Unit 2: Biocompatibility Standards and Guidelines (ISO 10993, USP
Biological Reactivity Tests)
โข Unit 3: Biocompatibility Testing Methods (Cytotoxicity, Sensitization,
Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity, Implantation)
โข Unit 4: Risk Assessment and Management in Biocompatibility
โข Unit 5: Biocompatibility Requirements for Medical Devices (Implantable,
Non-implantable, Combination Products)
โข Unit 6: Case Studies: Biocompatibility Challenges and Solutions
โข Unit 7: Biocompatibility Evaluation and Reporting
โข Unit 8: Regulatory Submissions and Approval Processes for Biocompatible
Medical Devices
โข Unit 9: Post-Market Surveillance and Biocompatibility
โข Unit 10: Emerging Trends and Future Perspectives in Biocompatibility
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