Biological Evaluation of Medical Devices: A Risk-Based Approach
This introductory course provides an overview of the biological evaluation of medical devices following the ISO 10993 standard international guidance. It offers a first-hand look at how to plan and conduct biological evaluations of medical devices and where such evaluations fit within the areas of design control and risk management.
This course covers the following topics:
- The ISO 10993 series of standards
- Biological evaluations and regulations
- Biological safety testing
- The risk management paradigm
Upon successfully completing this course, learners will be able to:
- Comprehend the regulatory framework relating to biological evaluations of medical devices
- Evaluate the need for devices to undergo biological evaluation
- Participate in and contribute to biological evaluation activities for medical devices
Development engineers, regulatory and quality associates needing an introduction to biological evaluation, regulatory professionals wanting an update of ISO 10993, and executive management employees who wish to oversee compliance-related aspects of biological evaluation are all encouraged to enroll in this course.
A basic understanding of the following course is required:
- ISO 13485: Foundation and Basic Principles (ID 196)