Part 1 provides you with fundamental knowledge to understand what is needed and why with regards to biological evaluation. One of the requirements, regardless of risk class, is that a biological evaluation report must be presented on final finished device. We have experience from diverse devices reviewed by various NB, FDA, and other agencies. From time to time we notice mistakes and gaps related to biocompatibility, causing unnecessary delays and expenses.
– Get to understand the requirements and avoid the most common pitfalls!
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 revisions of part 1 and 18, and the ongoing revision of part 17, even more emphasise will be on chemical characterization and a risk-based approach. The up-coming changes also increase the demand on knowledge.
After this course you will have increased knowledge and tools to perform biological evaluation and testing within a risk management process.
Day 1: Introduction to biological evaluation where we, among other things, review the following topics:
Day 2: How to perform a biological evaluation, focus on ISO 10993-1, -17 and -18
Biological evaluation in more depth, including among others:
Professionals working with design and development, project management, regulatory affairs or quality and people dealing with design changes.
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.
Note. To register for a public course/event – Use the button “ADD TO CART” above.
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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