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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230510005813/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network28.9.2026 10:00:00 CEST | Press release
Certification provides a defined security baseline for the network supporting Horizon3’s EU data sovereignty site in Germany Horizon3, the AI-Native Proactive Security Company, today announced that it has earned Cyber Essentials Plus certification covering its NodeZero AWS EU network. The network supports Horizon3’s EU data sovereignty site in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928143792/en/ Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network Organizations use NodeZero® to test production environments and find weaknesses attackers can exploit. When customers and partners assess the platform itself, they also need to understand the security standards applied to its supporting infrastructure. The Cyber Essentials certificate identifies a defined portion of that infrastructure and the baseline against which it was assessed. Developed by the UK’s National Cyber Security Centre, Cybe
Thales Expands Collaboration with Google Cloud to Help Secure Agentic AI Workflows28.9.2026 09:03:00 CEST | Press release
Integration enables new protections for communications between AI agents, models, enterprise data, and tools to help control what agents can access, share, and do Thales AI Security Fabric mitigates risks, brings enhanced visibility and policy enforcement to AI-driven workflows on Google Cloud Thales today announced an expanded collaboration with Google Cloud to help enterprises address emerging security and governance challenges associated with agentic AI, bringing integrated protection, visibility, and policy enforcement to AI-driven workflows on Google Cloud. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928647188/en/ ©Thales The integration of Thales AI Security Fabric with Google Cloud Gemini Enterprise helps organizations apply security, governance, and visibility across interactions among users, agents, models, and tools in real time. “Enterprises are moving from AI assistants to AI agents that can autonomously ta
SPORVIGILANCE Targets Safer Medicines and Billion-Euro Savings for Global Pharma Facing EU IDMP Fines28.9.2026 08:13:00 CEST | Press release
British regulatory technology company SPORVIGILANCE is targeting one of global pharma’s major compliance challenges with a platform offering a faster route to IDMP and SPOR readiness, compliance and governance. As the European Medicines Agency advances structured medicinal product data, companies face pressure to keep regulatory data accurate, standardised and aligned with EMA requirements. SPORVIGILANCE replaces fragmented manual assessment with a regulatory intelligence layer built around IDMP, SPOR and Product Management Service (PMS) requirements. At its core is an IDMP Business Rule Validation Engine that assesses medicinal product data at scale and at field level, identifying missing, inconsistent and non-compliant data. SPORVIGILANCE is the only platform to translate IDMP business rules directly into automated validation logic, enabling companies to test data against the rules rather than rely on manual interpretation. Its PMS Alignment capability reconciles internal RIM data ag
Sofinnova Partners Closes Oversubscribed €82 Million Sofinnova MD Start IV Fund to Create the Next Generation of Medtech Companies28.9.2026 08:00:00 CEST | Press release
The new fund extends Sofinnova’s 20-year track record of company creation with capacity to launch six to eight new ventures across Europe and the US Sofinnova Partners ("Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the final close of Sofinnova MD Start IV at €82 million. The fund, which was oversubscribed, will help expand Sofinnova's medtech company-creation strategy across Europe and the US with greater capacity to launch new ventures and support them through key stages of development. With plans to launch six to eight new medtech companies over the next five years, Sofinnova MD Start IV will support ventures from inception through key clinical and operational milestones, providing founders with both capital and hands-on support. Sofinnova MD Start's approach combines clinical insight, entrepreneurial talent, and operational expertise to tackle significant unmet medical needs. The previous fund, Sofinnova MD Sta
Ant International’s Antom Upgrades Southeast Asia Leadership Structure to Drive Regional Synergy in the AI Era28.9.2026 07:18:00 CEST | Press release
Antom, a leading merchant payment and digitisation services provider under Ant International, today announced a series of key appointments for its operations in Southeast Asia to further strengthen the synergy among its regional brands and better serve regional merchants with streamlined full-stack AI-native solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260927431282/en/ Nabilah Alsagoff, co-founder and former chief operating officer of DOKU, Indonesia's leading payment fintech company, has been appointed as Head of Product, Antom SEA. In her new role, the payment veteran will oversee product development and innovation and drive a unified product roadmap for the overall SEA region. Chris Yeo, former chief executive officer (CEO) of DOKU, will take on the role as Head of Antom Philippines, and Country Head of 2C2P Philippines. With his long experience at DOKU, Grab and PayPal, Chris will also oversee the execution
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom