Medical device manufacturers are busy preparing for MDR, while standards continue to be revised. The environment is constantly evolving – let WuXi Medical Device Testing be your guide. We provide world-class integrated consulting, testing and cGMP solutions that enable our clients to transform their ideas into life-changing healthcare solutions for patients and care givers. We are committed to delivering the global solutions needed to make that vision a reality – for companies big and small.
From 2011 – 2018, Dr. Parker developed the Risk Assessment program here at WuXi AppTec. She has always been committed to the program and its success. In Mike McGrew’s own words, Vice President of Medical Device Operations at WuXi AppTec, “We are thoroughly excited to have Dr. Parker back at WuXi AppTec, her commitment and participation within the global regulatory industry only enhances the expertise we bring to our customers.”
While at WuXi, Dr. Parker will provide our customers with guidance on global regulatory and technical requirements and designing test plans. Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology, and also an international and U.S. delegate for TC 194 says, “We are thrilled to have Dr. Parker back on the team, the knowledge and experience she brings is priceless.”
WuXi AppTec commits to collaborating with the medical device industry to push boundaries and innovate for the good of patients and caregivers globally. Our focus is to be an extension of your team, whether it is MDR or staying apprised of ISO 10993 updates.
Questions about MDR, global regulation updates or your medical device’s preclinical testing strategy? Contact us now to discuss your questions.
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 -
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.
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.
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.
WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.
Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have been introduced into the manufacturing process, is critical in determining the root cause of the microbial excursion, as well as effective corrective actions to prevent re-occurrence.
Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data.
Environmental monitoring is one way a device manufacturer demonstrates control within a production area. Environmental samples from water, air and surfaces support verification of process controls and ultimately support product safety. Trending this valuable data offers manufacturers a qualitative indicator of the cleanliness and controls within their production areas.
Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the endpoints you need to support your products’ safety.
A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers.
In last week’s blog post, we highlighted the importance of bioburden monitoring, both quantitatively and qualitatively, as supportive evidence for a valid radiation dose. We arrived at this conclusion through a historic data review of verification dose experiments.