Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO...
ISO 10993-1: The Importance of Chemical Characterization
Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again! Our Director of Analytical Chemistry, and International Delegate for ISO 10993 part 18, Sandi...
A Regulatory Consultant's Guide to ISO 10993 Updates Webinar
With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing...
Limited Space, Register Now for two SEMINARS. day 1: ISO 10993 Case Studies and day 2: dissecting the changes of iso 10993 part 18.
Join WuXi AppTec’s technical and regulatory experts as we share our experience with ISO 10993 and what that guidance means for today’s medical device manufacturers.
On the first day, our team will...
A Risk-Based Approach to Medical Device Testing Starts with Extractables and Leachables
As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.
And just as materials...
WuXi AppTec Names Mark Cunningham as Senior Director of Science and Technology
WuXi AppTec is pleased to announce that Mark Cunningham, Ph.D., has accepted the position of Senior Director of Science and Technology.
Dr. Cunningham brings more than 25 years of experience in...
WuXi AppTec Offers PTT Testing with BFT II Analysis
Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has...
WuXi AppTec to Exhibit at DeviceTalks Minnesota
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...
The Changing Landscape Of Medtech Regulation
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...