Biological Evaluation of Medical Devices, including Chemical Characterization

Date: 9th October 2019 -
10th October 2019
Time: 09:00 - 17:00
Duration: 2 Days
Venue: Raheen Woods Hotel, Athenry
Address: ***FULLY BOOKED***
Event details

Biological Evaluation of Medical Devices, including Chemical Characterization

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

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