Biological evaluation of medical devices, Part 1

Part 1 – Introduction to biological evaluation of medical devices

Course description:

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!

Course outline

One-day 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?
• The extended scope and safety requirements of hazardous materials/substances in MDR 2017/745
• 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

Who should attend

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.

Prerequisites

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.