Gabriel AduseiAssociate Director, Life Sciences at Guidehouse
Gabriel Adusei is an Associate Director in the Life Science practice in London. He is an experienced medical devices consultant with a passion for regulatory, risk management, clinical, quality and patient safety for medical technologies.
Gabriel’s expertise is in the design and development activities of medical devices, combination and software products. He advises manufacturers seeking compliance with medical standards and regulations globally with a focus on the US, UK, EU and other global regulated markets. He has experience of reviewing and preparing technical and regulatory documentation as well as formulating submission strategies. Gabriel has worked with EU notified bodies as Medical Device auditor and for a number of companies as a consultant, to achieve and maintain compliance with CE certification requirements. He also has first-hand pre-clinical and clinical trial experience in accordance with Good Clinical Practice (GCP) across the US and EU in accordance with the requirements of ICH and ISO 14155 Standards. He specialises in developing technical design dossiers, clinical evaluation reports, risk-management files and post-market safety reporting.
Gabriel has authored significant number of articles and White Papers, many of which have contributed to the regulatory and quality management developments in the medical technology industry.
Gabriel has a PhD in Biomaterial Science from King’s College London.