As industry analysts predicted, laboratory testing facilities are experiencing capacity constraints due to Europe’s Medical Device Regulation (MDR). To accommodate the high demand and help manufacturers meet the May 26, 2020 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
The expansion doubled the lab’s footprint to 12,000 square feet and increased the total facility space to 30,000 square feet.
“Many manufacturers are not tracking 'on schedule' for MDR implementation,” said Steve Yang, Executive Vice President and Chief Business Officer at WuXi AppTec. “Our investment to expand our chemistry capacity is intended to ease the burden on manufacturers and help them get access to the resources and expertise they need to efficiently get their products submitted for regulatory review.”
“The May deadline is fast approaching, and it’s not likely that Europe will grant an extension on MDR. A recent KPMG/RAPS survey of more than 200 medical device industry leaders found almost three-quarters don’t anticipate they will be fully compliant with MDR by the deadline,” said Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi Medical Device Testing. “At this point, the industry needs all hands on deck. Our chemistry team is here to not only conduct pre-clinical device safety testing but to help manufacturers understand and navigate the regulation.”
Failure to comply by the deadline will result in costly consequences, including having to retest devices or pull products from the market altogether—but thoughtful planning and partnership can help avoid challenges and delays. To secure your spot in line with WuXi Medical Device Testing, visit https://medicaldevice.wuxiapptec.com/contact-us/.
The expanded chemistry lab is located at 2520 Pilot Knob Road #100, Mendota Heights, Minn. WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.