Meet...
Mary-Ann Preston
Presenter
Mary-Ann Preston has over 30 years’ experience across a broad range of medical device technologies and organisations, from start-ups to multinational companies. She is the founder of her own consultancy, providing medical writing, technical, and strategic regulatory consultancy services to MedTech companies.
Mary-Ann has extensive expertise in the preparation and critical assessment of technical, scientific, and clinical documentation for regulatory submissions, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), PMCF plans and reports, literature reviews, PMS plans and reports, and PSURs. She has supported clients with regulatory strategy, remediation activities, and hands-on development of clinical documentation in line with MDR, IVDR, MEDDEV 2.7/1 Rev 4, MDCG guidance, and related standards.
She has held senior leadership roles within both consultancy and industry, including EMEA Manager for Medical Writing Services at NAMSA and Clinical Practice Manager at RQM+. In these roles, she led teams of medical writers responsible for developing regulatory and clinical evaluation documentation for medical devices and IVDs.
Prior to specialising in regulatory and clinical writing, Mary-Ann spent more than 20 years in medical device R&D, including roles at Smith & Nephew. Her experience spans device design and development, pre-clinical research, biocompatibility testing, and in vivo safety and performance studies supporting regulatory submissions. She has particular expertise in dermal wound healing, sports medicine, and orthopaedics.
Mary-Ann is trained as a biochemist and cell biologist and holds a PhD in dermal wound healing and scarring.
