Adrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was previously Head of Notified Body for the UK Notified Body SGS. Prior to that he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Devices Directive.
In this role he combines his experience from new product development with EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.
Adrian has 25 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the Notified Body LRQA. Prior to that he worked in the medical device industry, latterly as Global Product Safety Manager at Smith and Nephew. Here he created a highly effective team delivering product safety and risk management to Smith and Nephew’s global wound management portfolio. His team was responsible for providing toxicological and risk management strategies to expedite product launches, commercialisation, and post market activities, including Far Eastern markets (Japan and Korea).
He joined Smith & Nephew directly from The School of Pharmacy (University of London) following postgraduate research in retinoid-induced skeletal toxicity and an honours degree in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute.
Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and has been an active participant in NB-MED and NBRG.
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.