About
This course provides a comprehensive overview of biocompatibility in medical technology, focusing on the ISO 10993 series of standards. Participants will explore the principles of biological evaluation, material characterization, and the selection of materials for medical devices. The curriculum addresses risk assessment workflows, specific testing protocols for various contact durations, and the regulatory requirements for global market access. By the end of the program, learners will understand how to implement a structured biological safety evaluation plan for MedTech products using direct, factual frameworks.
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Overview
- Defining Biocompatibility in MedTech
- Overview of ISO 10993 Standards
- Regulatory Context and Compliance
- Introductory Quiz
- Identifying Nature of Body Contact
Instructors
Price
R 999,00