Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers

Release Date
January 17, 2019 10 AM EST U.S. (4 PM UTC)

View recorded webinar here!

Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning.

This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact of this new standard and address updated requirements for the orthopedic industry.

Provided will be information on:

Time will also be allotted for Q&A.

View recorded webinar here!

About the Presenter:

 

Nicola Revellin, PhD is a Senior Medical Research Scientist in our EU Biological Safety and Validation group in NAMSA’s Lyon, France office. Nicola has a PhD in Microbiology, and she started as a study director in the Microbiology labs with NAMSA in 2008. In addition to this role, she joined the Technical Advisor team within the Lyon lab in 2009 and also supervised microbiology study directors prior to her transition to her current role. She has delivered multiple training sessions to clients and Notified Bodies surrounding sterilization validation for single use devices as well as re-processing for re-usables.