Biological evaluation of Medical Devices

Part 1 – Introduction to biological evaluation of medical devices

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 – How to perform a biological evaluation, focus on ISO 10993-1, -17 and -18

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.

Course content

Day 1: Introduction to biological evaluation where we, among other things, review the following topics:

• What is the definition of biocompatibility and why is testing needed?
• ISO 10993 standard series – an overview
• The relation between ISO 10993 and the risk management standard ISO 14971
• Which product types and materials are in the scope?
• What characterizes a “smart” choice of material?
• Material characterization, typical methods to be used and what kind of information can be achieved?
• Can animal tests be avoided?
• What you should consider in the communication with test-house and consultants
• Guidance on changes that could alter the biological safety of a final device
• ”Common pitfalls” – avoid the typical mistakes
• Group discussions with practical examples for exercises

Day 2: How to perform a biological evaluation, focus on ISO 10993-1, -17 and -18
Biological evaluation in more depth, including among others:

• The Biological Evaluation Plan and its parts – a structured way to connect ISO 10993 with risk management and identify appropriate testing strategies
• The Biological Evaluation Report – key elements to be covered (and what the reviewer wants to see)
• ISO 10993-1, -17 and -18 – Upcoming changes; what we know today
• Selection of chemical testing methods for material characterization and the use of results
• Points to consider when using chemical characterization to reduce the number of animal tests
• Extractables and Leachables, part 18 – Basics on performance and important points to consider
• Toxicological assessments, part 17 – – Basics on performance and important points to consider
• Group discussions with practical examples for exercises

Who should attend

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.

Previous knowledge level

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.

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