Quality Training

Biological Evaluation of Medical Devices, including Chemical Characterization

Objectives

This 2-day training course will describe the big-picture concepts of biological evaluation of medical devices providing a wide and comprehensive overview of the main relevant key topics and critical aspects. It offers a first-hand look at how to plan and conduct the biological evaluation, and, more importantly, how such an evaluation sits within the activities of design control and risk management by giving practical hints for the definition of pathways based on scientific rationales.

Content includes

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
Understanding and knowing the device as first crucial step to approach biological evaluation
Chemical characterization of the materials: what does it means in practice
Extractable/Leachable studies as a perfect way to characterize many medical devices
Toxicological assessment (ISO 10993-17) application in order to evaluate obtained data from chemical characterization
Bridge approach and change management optimization thanks to chemical characterization
Biocompatibility tests overview:

o The big 3: cytotoxicity, irritation, sensitization

o Acute effects evaluation: acute systemic toxicity, pyrogens and endotoxin tests

o Long term studies implantation and systemic toxicity studies

o Genotoxicity: the new ISO 10993-3 and ISO 10933-33 approach and requirements

o The difficult evaluation of devices in contact with blood
Biocompatibility testing acceptance by international authority: accreditation requirements and philosophical differences
Case study
Q & A Session

Who should attend

Medical Technology Professionals

Qualification

Certificate of Attendance

Upcoming dates:

No training dates available at the moment.