Adrian Keene

Adrian Keene has more than 30 years of experience in product development and registration within the medical device industry, with both manufacturer and regulatory agency perspectives. He holds significant expertise in managing the new product development process and regulatory submissions to meet expectations of both regulatory agencies and manufacturers. He has a particular focus on high-risk products (Class III including drug-device combinations and IIb implantable devices), clinical evaluation, and biocompatibility. Adrian also has extensive experience managing 3rd party relationships, including the UK competent authority (MHRA). He is practised at operating within global multi-disciplinary teams, and coaching and developing staff.

CORE COMPETENCIES

• EU Medical Devices Regulatory Requirements and Processes
• EU MDR 2017/745 and MDD 93/42/EEC
• CE Marking of Medical Devices
• Clinical Evaluation
• Post Market Clinical Follow Up
• PMS/Vigilance
• ISO 10993 Biological Evaluation of Medical Devices
• ISO 14971 Risk Management of Medical Devices
• New Product Development
• Developing Regulatory Strategies
• People/Team Management
• Preclinical 3rd Party Management
• Co-opted member of BSi Committee CH/194 (revising and developing Biological Evaluation of Medical Devices standards in the ISO 10993 series).
  • UK technical expert for TC/194 (Biological Evaluation of Medical Devices).
• Regular external speaker (UK and internationally), author of chapter in publication “Biocompatibility and Performance of Medical Devices (2020, Woodhead Publishing, Ed. Jean-Pierre Boutrand).