Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations -
WuXi AppTec, a longtime member of the AATB, returns for the 42nd Annual Meeting, October 9-12, 2018.
The AATB annual meeting, held in Dallas, Texas, this year, encompasses a vast array of continuing education classes, breakout sessions and an expo. The meeting brings together suppliers, manufacturers and end users within the tissue-product ecosystem.
Associate Director of Regulatory Toxicology, Dr. Vanessa Haase, will present the case study at the Q1 Productions Medical Device Sterilization conference on September 24, 2018.
The most recent version of ISO 10993 Part 1, published in August 2018, emphasizes the need for biological evaluations to begin with chemical characterization. In this case study, Dr. Haase outlines a risk-based approach to device preclinical safety in accordance with ISO 10993. The case study, which features a blood-contacting device, summarizes chemical characterization, toxicological risk assessment and a biocompatibility test strategy for evaluating the relevant biological end points. Dr. Haase will speak at 11:15 am on September 24.
WuXi AppTec will be an exhibitor at DeviceTalks Minnesota, June 4-5, 2018, in St. Paul, Minnesota.
DeviceTalks showcases the latest information on clinical trials, regulatory, technology and the medical device industry ecosystem.
Visit the WuXi AppTec exhibitor booth, #306, and connect with one of our many representatives. We anticipate lively discussions and fresh perspectives on the success, obstacles and future direction of the medical device industry. We also look forward to participating in the conference’s Clinical, Regulatory, Technology and Ecosystem tracks.
WuXi AppTec returns to E&L USA this May in Bethesda, MD.
PLEASE JOIN US ON THURSDAY MAY 3RD FROM 3:00 PM TO 4:30 PM FOR “THE CHANGING LANDSCAPE OF MEDTECH REGULATION,”
UNIVERSITY ENTERPRISE LABORATORIES (UEL) WITH SPEAKER DR. VANESSA HAASE, ASSOCIATE DIRECTOR OF REGULATORY TOXICOLOGY FOR WUXI APPTEC INC., ST. PAUL, MN.
Where: UEL, 1000 Westgate Drive, St. Paul, MN 55114,
1st Floor Conference Room – South Entrance