Basic Training in Biological evaluation of Medical Devices

This course provides you with fundamental knowledge to understand how and when a biological evaluation of a medical device should be performed. It is based on the recent new issue of the fundamental standard ISO 10993-1:2025 and outlines the structure of the biological evaluation and how to plan and conduct a biological evaluation within a risk management process. You will obtain a working knowledge in how to decide if and when to perform novel tests, strategies to reduce the testing need, and important aspects to think of when it comes to ordering/performing tests from a CRO.

The course will provide you with a basic understanding of the chemical characterization process and toxicological risk assessment framework required for a true risk-based approach. The course content is illustrated with our own experiences from testing and evaluation of medical devices for biocompatibility, as well as experiences from interactions with notified bodies and other authorities.

After this course you will have increased knowledge about the requirements on biological safety that your finished product will need to fulfill, and an understanding both of how this is evaluated and how it is documented for review by authorities. You will also get familiar with the tools to be used to perform the assessment.

The course is a basic course intended to give a broad overview of the area and expertise to understand concepts and perform basic biocompatibility assessments. For already experienced professionals, we also offer an in-depth advanced course.

Course content

Basics of biological evaluation where we, among other things, review the following topics:

• What is biocompatibility and why is a biological evaluation needed?
• Biological tests – overview of different parts of ISO 10993
• Structure of the biological evaluation
• MDR, FDA and biocompatibility requirements
• Overview of chemical characterization and toxicological risk assessment (ISO 10993-18 and ISO 10993-17)
• Practical aspects of testing medical devices
• ”Common pitfalls” – avoid the typical mistakes
• Group discussions with practical examples as exercises

Who should attend

Everyone who needs an understanding of the biological evaluation requirements, e.g. biocompatibility responsible persons, or professionals working with design and development, project management, regulatory affairs or quality assurance. The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer’s needs and requirements.

Previous knowledge level

To be able to grasp and make use of the course content you should have basic knowledge of medical devices and the associated regulations.

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