Advanced Training in Biological Evaluation of Medical Devices

This course provides you with in-depth knowledge to be able to perform a biological evaluation according to ISO 10993-1. This course is intended for already experienced professionals wishing to gain further insight into the subject. For an introduction to the field, please see our basic biocompatibility course.

This course gives a recap on the structure of a biological evaluation and how to plan and conduct a biological evaluation within a risk management process, also over the whole life cycle of the device. With the revisions of ISO 10993 part 1 and 18 in 2018 and 2020, respectively, and the recently completed 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. The course will provide you with an in-depth understanding of the chemical characterization process and toxicological risk assessment framework. It includes practical exercises on how to interpret supplier information, how to perform toxicological risk assessments and on how to determine required sensitivity in chemical tests (AET). The course also discusses strategies to reduce the amount of animal tests and gives information on available in vitro tests and how to include such data in a risk-based approach to biological safety evaluation.

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 be prepared for independently carrying out a biological evaluation, with increased knowledge about the requirements on biological safety that your finished product will need to fulfill, and practical experience of how to do this evaluation and document it for review by authorities. You will also get familiar with the tools to be used to perform the assessment within a risk management process, especially how to do calculations for toxicological risk assessments.

Course content

Biological evaluation – why and how. Chemical evaluation and toxicological risk assessment

• Short recap of biological evaluation:
  • How to do biological evaluation in a risk-based manner
  • Biological tests – overview of different parts of ISO 10993
  • Sample preparation – how may your choices affect results?

• Chemical characterization – theoretical and practical
  • Get the most out of supplier information
  • How to design experimental studies in accordance with ISO 10993-18
• Toxicological risk assessments, part 17 – get familiar with the standard and learn to use it

• Case studies and workshop

Biological evaluation in different countries and for different devices; different approaches to evaluation and testing

• What is required for biological evaluation in different jurisdictions? (EU MDR, US FDA, etc.)
• Other biocompatibility standards:
  • ISO 18562 series (respiratory gas pathways)
  • ISO 7405 (dentistry)
  • ISO 11979 series (ophthalmic implants)

• ”Common pitfalls” – avoid the typical mistakes
• Strategies for minimizing the need for animal tests
• How to handle changes
• Case studies and workshop

Who should attend

Everyone with prior knowledge on biocompatibility assessment who needs a deeper understanding of the biological evaluation requirements, e.g. professionals with responsibility for biocompatibility assessments, or professionals working with design and development, project management, regulatory affairs or quality assurance.

Previous knowledge level

Everyone with prior knowledge on biocompatibility assessment who needs a deeper understanding of the biological evaluation requirements, e.g. professionals with responsibility for biocompatibility assessments, or professionals working with design and development, project management, regulatory affairs or quality assurance.

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