PA-RQM+
10.5.2023 20:09:27 CEST | Business Wire | Press release
RQM+, the world’s leading MedTech service provider, today announced the acquisition of Libra Medical, a full-service contract research organization (CRO) that specializes in early-stage clinical trials. Founded in 2007, Libra Medical provides regulatory affairs, clinical operations and quality assurance services to companies that develop complex medical devices and diagnostics products. Libra’s studies take place in the United States, Europe, Australia and Latin America.
“Libra’s deep expertise with first-in-human (FIH) studies for complex devices and diagnostics is an excellent complement for our clinical trials business,” said RQM+ CEO Margaret Keegan. “We will take our clients seamlessly from FIH pilot studies to pivotal to commercial trials all within the same organization while also offering them reimbursement, lab testing and regulatory consulting as their needs evolve. We are honored to have Dr. Tay, the founder of Libra Medical, join RQM+ to continue the strong relationships she has established with the early-stage MedTech community and the FDA.”
With more than 20 years of MedTech expertise, Libra Medical CEO Sew-Wah Tay was the vice president of regulatory and clinical affairs at American Medical Systems (AMS). She also served in leadership roles at multiple MedTech startups, St. Jude Medical and Boston Scientific.
“I am thrilled to now be able to offer my clients a seamless transition from FIH to pilot to pivotal studies,” said Tay. “I look forward to continuing my relationship with clients throughout their product lifecycle by providing them a long-term partnership and comprehensive services through RQM+.”
Tay holds a doctorate degree in biomaterials, a master’s degree in food science and a master’s degree in chemical engineering from the Massachusetts Institute of Technology. She also holds a bachelor’s degree in food science and technology from the University of Pertanian Malaysia.
About RQM+
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. For more information, visit RQMplus.com.
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