The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. This webinar will describe the big-picture concepts of biological evaluation of medical devices providing key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices.
As a previous active member of ISO committees in addition to extensive experience in the medical device industry, our expert Paolo Pescio, ERT, HAS Consulting, and Scientific Director at Eurofins Medical Device Testing, brings a wealth of knowledge and a unique perspective to this topic and provides valuable considerations on how to approach the biological evaluation of medical devices.
Benefits of attending:
Understand biological risk management
Clarify the requirements of ISO 10993-1
Learn what endpoints need to be addressed in a biological risk assessment
Establish how much chemical characterization is necessary
Regulatory approach (MDR, FDA)
Agenda
Introduction to biological evaluation concepts, within the framework of medical devices global regulation
ISO 10993 standard series: approaching biocompatibility within the whole device risk management process
Case study
Q&A session
