Mary-Ann Preston is the EMEA manager for medical writing services at NAMSA, a medical research organization providing full-service support throughout the product development process for medical devices, diagnostics, and combination products.
Mary-Ann is responsible for a team of medical writers who prepare clinical evaluation reports (CER), performance evaluation reports (PER), and other documents in accordance with regulatory requirements (e.g. Medical Device Regulation and In vitro Diagnostic Regulation), various guidance (e.g. MEDDEV 2.7/1 revision 4 and medical device coordination group documents) as well as other applicable documents and standards. She has extensive experience in the critical assessment and interpretation of technical, scientific, and clinical data for CERs, PERs, literature reviews, scientific reports, and regulatory submissions. Utilizing her strong background within the medical devices industry, Mary-Ann has provided regulatory consultation, remediation, and hands-on assistance to clients on all aspects of PERs and CERs.
As well as clinical expertise, Mary-Ann has over 20 years of R&D experience in medical devices. Her background includes the design, development, and management of pre-clinical research for medical devices from scoping, and proof of concept stage through to pivotal development, biocompatibility testing, and in vivo safety and performance studies for regulatory submissions. She has developed medical device expertise in the therapeutic areas of dermal wound healing, sports medicine, and orthopaedics.
Mary-Ann is a biochemist and cell biologist by training, with a Ph.D. in dermal wound healing and scarring.
Before joining NAMSA, she held various senior roles at another consultancy and a leading manufacturing company, Smith & Nephew.
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents