Regulatory and validation
By combining technical knowledge with regulatory awareness, I help clients strengthen their evidence base, streamline certification processes, and ensure that medical devices meet the highest standards of safety and performance.
Regulatory documentation and Clinical Validation
I combine scientific expertise with a strong understanding of regulatory and validation processes, supporting the safe and effective translation of medical technologies from research to clinical application. My experience covers the preparation of technical and clinical documentation for CE marking, the implementation of quality management systems, and the development of validation frameworks for medical devices.
Regulatory Documentation and Compliance
I have authored, collaborated and reviewed a wide range of regulatory documents, including Clinical Evaluation Protocols, Clinical Evaluation Reports, and Biological Evaluation Reports. My work has supported compliance with ISO 60601-1/-2, ISO 10993, and EU MDR frameworks, ensuring that device safety and performance evidence meets international standards.
I have assisted in QMS audits, contributing to the preparation and review of documentation in line with BSI and European standards. This has included internal technical reviews, risk management compliance, and audit support for certification processes. My work ensures that organisations can confidently demonstrate adherence to regulatory standards while maintaining the flexibility required for innovation.
Validation of Medical Devices
In both academic and industry roles, I have designed and implemented validation studies for novel technologies. This includes developing test protocols for in vitro diagnostic devices, designing quality control systems for biological samples, and conducting risk–benefit analyses for device performance. By combining different analytical methods and experimental design, I ensure that validation processes are robust, reproducible, and clinically meaningful.
Clinical Trials Experience
I have hands-on experience in the management of clinical trials, supporting projects from initial set-up through to successful completion. This includes coordinating trial design, preparing study documentation, and ensuring compliance with Good Clinical Practice (GCP) guidelines and ethical standards.
As a clinical trial manager, I have worked closely with investigators, healthcare professionals, and research teams to establish study protocols, oversee participant recruitment, and monitor trial progress. I have also contributed to data validation, risk management, and reporting processes, ensuring that studies deliver robust and reliable evidence to support medical device performance and safety claims.
My involvement extends beyond trial coordination to include training of clinical staff, developing technical competency in device operation, and supporting quality assurance throughout the trial lifecycle. I also have experience liaising with regulatory and certification bodies, aligning clinical investigations with broader device development and approval strategies.
Through this experience, I provide consultancy that strengthens the design, management, and delivery of clinical trials, helping organisations generate the evidence needed to advance their technologies into clinical practice.