Kanchana Iyer has more than 10 years of experience in medical devices and global regulatory affairs across multiple therapeutic areas including cardiovascular disease and diabetes. Kanchana’s experience within the industry spans a range of medical devices including hardware devices, in vitro diagnostics, embedded software, and software as a medical device (SaMD) and digital health technologies. She has led regulatory strategy development on complex medical devices for smaller startups and more established medical device companies. Her expertise on the premarket side includes developing pre-submission packages, negotiating with FDA and other regulatory bodies, breakthrough device designation, 510(k)s, De Novo requests, IDEs, and PMAs. Kanchana has also led post-market activities including developing 522 Order studies, adverse event and Medical Device Reporting, real-world evidence vigilance, and working directly with Office of Compliance and Office of Surveillance and Biometrics at FDA.
Prior to joining Halloran, Kanchana regularly negotiated with FDA and global regulators to get novel hardware and software technologies such as the artificial pancreas and clinical decision support tools to market more efficiently. Kanchana began her career as a premarket reviewer in the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health (CDRH) at FDA. She tackles complex scientific questions for novel technologies by integrating her experience as a reviewer and regulatory strategist.