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Ana Burman, PhD (she/her/hers)

Head of Regulatory and Qualoity
Flok Health

Ana Burman is a Regulatory and Quality Leader based in Cambridge, UK, with over a decade of experience delivering regulatory strategy, quality systems and design assurance for medical device and SaMD products. At Flok Health she leads regulatory and quality activities to ensure safe, compliant product delivery in hybrid clinical–commercial environments. Previously at Deloitte she developed and executed regulatory strategies and established the QMS that supported Deloitte MCS’s MHRA registration and the UK market placement of Clinify ReferAssist.

Ana combines deep technical knowledge of the Software Development Life Cycle, risk management, and ISO/MDR requirements with hands‑on experience in QMS implementation, audits, CAPA, and technical documentation. At BrightInsight and earlier roles she provided design assurance for Class I–IIb software, introduced robust risk management files, validated software and processes, and supported CE/technical file compilation for complex systems including surgical robotics. She routinely partners with engineering, product and clinical teams to translate regulatory requirements into practical, scalable controls within Agile development frameworks.

Ana holds a PhD in Management Information Systems (Health Informatics) from Brunel University, a MSC in IT Security from Westminster University, and CISSP certification. Ana is committed to advancing safe, compliant digital health solutions through pragmatic regulatory leadership and continuous quality improvement.

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