Sam Brusco, Associate Editor05.10.23
RQM+, a medtech service provider, has acquired full-service contract research organization (CRO) Libra Medical. Libra specializes in early-stage clinical trials.
Libra Medical offers regulatory affairs, clinical operations, and quality assurance services for companies developing complex medical devices and diagnostics products. Libra’s studies occur in the U.S., 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,” RQM+ CEO Margaret Keegan told the press. “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.”
Libra Medical CEO Sew-Wah Tay has over 20 years of medtech expertise, having been VP of regulatory and clinical affairs at American Medical Systems (AMS). She has also been in leadership positions 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+.”
Last year, RQM+ acquired medtech and IVD regulatory, quality, and clinical consulting services firm AcKnowledge Regulatory Strategies. The company also acquired Jordi Labs, adding chemical characterization and complex product deformulation as well as contaminant and failure investigations to its portfolio.
Libra Medical offers regulatory affairs, clinical operations, and quality assurance services for companies developing complex medical devices and diagnostics products. Libra’s studies occur in the U.S., 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,” RQM+ CEO Margaret Keegan told the press. “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.”
Libra Medical CEO Sew-Wah Tay has over 20 years of medtech expertise, having been VP of regulatory and clinical affairs at American Medical Systems (AMS). She has also been in leadership positions 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+.”
Last year, RQM+ acquired medtech and IVD regulatory, quality, and clinical consulting services firm AcKnowledge Regulatory Strategies. The company also acquired Jordi Labs, adding chemical characterization and complex product deformulation as well as contaminant and failure investigations to its portfolio.