This course provides you with in-depth knowledge to be able to perform a biological evaluation according to ISO 10993-1. It 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.<\/p>\n
It provides 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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n