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 10993-18 as part of TC 194 / Working Group 14.

Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

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 Schaible explains why chemical characterization should be the driver behind your biocompatibility testing plan.

Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

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 alone to obtain regulatory approval.

Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

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 share case studies regarding how Global Regulatory bodies currently interpret the guidance. As part of the working groups, our team will also share the upcoming changes to ISO 10993 parts 1, 17 and 18 and what those changes may mean moving forward for medical device manufacturers.

The second day is a deep this deep-dive into ISO 10993 Part 18. Sandi Schaible will look at the upcoming changes to ISO 10993 part 18 and what they may mean to chemical characterization test plans in the future. 

Topics: Medical Device, Preclinical Safety, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants

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 characterization plays a role in device design and development, extractables and leachables studies play a role in regulatory submission and preclinical safety testing.

WuXi AppTec works with you to first determine the best analytical approach for your medical device. We help you determine testing parameters, based on the device’s classification and indication for use (such as the intended population, route of administration and clinical application).

Topics: Medical Device, Leachables, Preclinical Safety, Extractables, Biological Safety Testing, Regulatory, consultant, Technical Expertise

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 the biopharmaceutical and contract research organization (CRO) industries supporting the R&D of pharmaceutical, biotech, medical device and combination products.

Topics: Contract Research Organization, Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, Scientific Director, consultant, Technical Expertise

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 indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.

Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility

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.

Topics: Medical Device, Preclinical Safety

WuXi AppTec returns to E&L USA this May in Bethesda, MD.

Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, Biological Safety Testing, E & L

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

Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory