The first part provides you with fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed. This first part outlines the structure of the biological evaluation and how to plan and conduct a biological evaluation within a risk management process. The course will also provide you with a working knowledge of the different biological tests available. We also share our experience related to selection of materials and experience from notified bodies.
– Get to understand the requirements and avoid the most common pitfalls!
With the revisions of ISO 10993 part 1 and 18 in 2018 and 2020, respectively, and the ongoing revision of part 17, more emphasis is put on material characterization and a risk-based approach. In addition, MDR also sets higher demands on substances contained in and released from devices. This part of the course will provide you with a detailed understanding of the chemical chacterization process, and also important aspects to think of when it comes to ordering/performing tests for the biological evaluation.
After this course you will have increased knowledge and tools to perform biological evaluation and testing within a risk management process.
Day 1: Basics of biological evaluation where we, among other things, review the following topics:
Day 2: Practical aspects of testing, Material characterization and toxicological evaluation, focus on ISO 10993-12, -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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