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David J. Mandley, PhD

Principal Regulatory Consultant
NAMSA

Dr Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.

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