Executive Development Programme in Biocompatibility & Product Strategy
-- ViewingNowThe Executive Development Programme in Biocompatibility & Product Strategy is a certificate course designed to provide learners with critical skills in the field of medical devices. This programme emphasizes the importance of biocompatibility, a key factor in product safety and efficacy, and its role in product strategy decisions.
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⢠Introduction to Biocompatibility: Fundamentals of biocompatibility, medical device materials, and their interactions with the human body.
⢠Regulatory Landscape: Overview of global regulatory bodies and their requirements for biocompatibility testing.
⢠Biocompatibility Testing Methods: In-vitro and in-vivo testing methods, selection criteria, and interpretation of results.
⢠Risk Management: ISO 14971, risk identification, assessment, and control in the context of biocompatibility.
⢠Case Studies: Analysis of real-world biocompatibility challenges and solutions in medical device product development.
⢠Product Strategy: Aligning biocompatibility with product development, market positioning, and commercialization strategies.
⢠Design Controls & Documentation: Implementing and maintaining design controls, and creating clear, comprehensive documentation for biocompatibility.
⢠Clinical Evaluation & Performance: Understanding clinical performance, evaluation, and demonstrating equivalence in biocompatibility.
⢠Supply Chain Management: Ensuring biocompatibility throughout the entire supply chain.
⢠Communication & Collaboration: Effective communication and collaboration with cross-functional teams, stakeholders, and regulatory authorities.
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