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, US 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!
One-day introduction to biological evaluation where we, among other things, review the following topics:
People working with design and development, project management, regulatory affairs or quality; and people dealing with design changes. The training course provides you with the fundamentals needed to understand what to consider when performing a biological evaluation from choice of materials to the final product.
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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