Our
Story
​​​Every great innovation in healthcare begins with a commitment—to improve lives, uphold safety, and deliver excellence. CQURA was founded with that very commitment at its core. Our name—CQURA—stands for Clinical Quality, Usability, Regulatory Advisory, reflecting the pillars of expertise we bring to every partnership.
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Established by Dr Shweta Agarwal, PhD—a seasoned leader with over 15 years of experience in biomedical engineering, medical device development, and regulatory consulting—CQURA was created to address a critical need of bespoke regulatory, quality and clinical solutions that support and drive innovation in the MedTech industry.
Throughout her career, Shweta worked alongside startups and global manufacturers alike, witnessing firsthand the limitations of standardised, one-size-fits-all solutions in a highly regulated and rapidly evolving environment.​ She recognised that true success in MedTech demands more than generic guidance. It requires strategic, tailored solutions rooted in technical expertise, clinical insight, and a deep understanding of regulatory complexities. Driven by a passion for clinical excellence, quality assurance, and patient well-being, Shweta founded CQURA to deliver precisely that.
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Today, CQURA is a trusted partner to innovators across the MedTech spectrum—including manufacturers of medical devices, in vitro diagnostics (IVDs), drug-device combinations, software as a medical device (SaMD), wellness technologies, and digital health products. At CQURA, we offer bespoke, high-impact consulting services designed to help our clients overcome regulatory, clinical, and quality challenges with confidence.
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What sets CQURA apart is our approach. We don’t simply advise—we collaborate. By embedding ourselves within the clients' team, aligning with their objectives, and delivering agile, actionable support, we ensure that our clients are not only compliant but also strategically positioned for success in an increasingly competitive market.
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We believe that when MedTech innovators are empowered with the right expertise and guidance, they can accelerate the speed of innovation— delivering safer, smarter, and more effective healthcare solutions to the people who need them most.
Meet Our Experts
At CQURA, our experts are seasoned professionals with deep expertise across biomedical engineering, regulatory strategy, quality systems, usability, and clinical affairs. Each member brings a unique perspective shaped by years of hands-on experience in the life sciences and medical device industries. What unites us is more than our credentials—it’s a shared commitment to delivering impactful, compliant, and patient-focused solutions that drive innovation and improve lives. With CQURA, you don’t just get consultants—you get trusted partners at every step of your journey.
