Part 2 offers knowledge about how to plan and conduct a biological evaluation within a risk management process. Focus is on the main part of the standard, ISO 10993-1, but also on part 17 and 18. With the revision of part 1, even more emphasis will be on chemical characterization and towards a risk based approach. The up-coming changes also increase the demand on knowledge. After this course you will have basic knowledge and tools to perform biological evaluation and testing within a risk management process.
Second part of the course with focus on the biological evaluation process, including among others:
People working with design and development, project management, regulatory affairs or quality.
The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer needs and requirements.
To be able to grasp and make use of the course content you should have basic knowledge of the medical device regulation with respect to design control.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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