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Dr Andrew Mkwashi
Dr Andrew Mkwashi profile picture
  • Research Fellow in Regulation and Standardization of Connected, Intelligent Medical Devices (REG-MEDTECH)
  • STEaPP
  • Faculty of Engineering Science
Dr Andrew Mkwashi is an interdisciplinary researcher with an academic background in regulatory science, business administration, and computer science. He has extensive industry and policy engagement experience, as well as great teaching and consultancy experience. He holds a Bachelor of Science Honours degree in Computer Science from London School of Management, a Master of Business Administration (MBA) from the University of Bedfordshire, United Kingdom, and a PhD in Regulatory Science from The Open University, United Kingdom.
Research Summary
Dr Mkwashi's research interests are on the regulation, standardization and development of health technologies, the governance of emerging regulatory frameworks, the certification processes of emerging technologies, international development, Internet of Medical Things (IOMT) Cybersecurity, and exploration of Artificial Intelligence (AI) based medical devices, data governance and policy issues in regulatory science.

Currently, Andrew is working on a research project on "Regulation and Standardization of Connected, Intelligent Medical Devices (REG-MEDTECH)" which seeks to understand the extent to which current regulatory frameworks and standards address the critical challenges and unique risks posed by Connected, Intelligent Medical Devices (CIMDs) and provide possible solutions to these challenges. The REG-MEDTECH is an EPSRC-funded project, part of the prestigious PETRAS National Centre of Excellence on IoT Systems Cybersecurity.

Andrew's PhD examined the influence of healthcare systems regulation on industrial capabilities and affordable healthcare technologies using case studies from the UK and South Africa. His research focused on the EU regulatory policy and law, development and commercialization of healthcare technologies in general and medical devices in particular. He explored issues such as regulatory planning and policy, global product strategy, product lifecycle strategy, regulations and standards management (such as ISO 13485 - Quality Management System, ISO 14971 - Application of Risk Management and IEC 62304 - Software Life Cycle Processes), impact of medical device regulations on innovation, legal requirements placed on medical devices and In Vitro Diagnostics (IVDs) approval and CE marking process.

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