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.
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.
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.
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.
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.
Dr Shweta Agarwal
Director & Principal Consultant
Shweta Agarwal, PhD, is a biomedical engineer with over 15 years of experience guiding medical device manufacturers through regulatory strategy, quality assurance, and product development across the US, EU, and UK. With expertise in US 510(k), EU MDR, and CE certification, she is passionate about advancing patient safety and clinical excellence in MedTech innovation.
Ghazaleh Hofmann
Management Consultant
Ghazaleh Hofmann is a biomedical engineer with experience in healthcare business, market strategy, and regulatory processes, focusing on digital health and medical technologies across European and global markets. With a background in sales, business development, and consulting, she excels at aligning technical solutions with clinical needs to drive product adoption and market growth.
Professor Sergio Bertazzo
Senior Scientific Advisor
Sergio Bertazzo, PhD, is a Professor at UCL’s Department of Medical Physics & Biomedical Engineering, with research focused on the formation, behaviour, and nature of minerals in biological contexts. He also advises on material characterisation and biocompatibility related to medical devices, drawing on his expertise in biomaterials and nanotechnology.
Paula Burge
Senior Regulatory/Quality Advisor
Paula Burge is a regulatory and quality consultant with 30 years of experience supporting companies in the device, diagnostics, and combination product industries. She specialises in design and development for manufacturers complying with U.S., European, and international standards. She can provide extensive experience in aiding organisations to define and document design controls, human factors, and risk management deliverables.
Dr Alex Charitou
Senior Advisor
Alex Charitou is a senior MedTech advisor and former EY partner with nearly 30 years of experience in healthcare and life sciences. He has supported global MedTech manufacturers in bringing innovative technologies to patients efficiently and safely. He has a particular interest in Digital Health technologies and is recognised as a subject matter expert in European regulatory frameworks and commercial strategy.
Scott Thiel, MBA, MT (ASCP), RAC
Senior Advisor
Scott Thiel is a seasoned medical device regulatory affairs leader with over 30 years of experience helping companies deliver life-saving technologies worldwide. He is recognised for strategic leadership, aligning cross-functional teams, building scalable compliance systems, and shaping global regulatory conversations on software, interoperability and AI, driving innovation while ensuring safety, effectiveness, and long-term success.