Dr. Bowness was a decision maker and regulatory and technical specialist for the EU Notified Body and UK Approved Body, BSI, where he led the biologics technical team.
At BSI, Dr. Bowness was the subject matter expert on risk management for medical devices under ISO 14971, information to be provided to users under ISO 20417 (replacing EN 1041), graphical symbols for medical devices under ISO 15223 and procedure packs under Directive Article 12 and Regulation Article 22 and wrote procedures and guidance on the interface between risk management, clinical evidence, PMS/PMCF and information provided to users.
Dr. Bowness worked in industry for 8 years, running stability and drug release testing for recombinant antibody therapeutics in a GMP testing laboratory and in medical device R&D, leading projects to develop animal tissue collagen implants for guided tissue regeneration in a range of clinical applications.
In addition, Dr. Bowness is chair of the British Standards Institution technical committee CH/210/WG3 and Member ISO/TC/210 (Quality management and corresponding general aspects for medical devices), Member CH/210/04 (Risk analysis for Medical Devices) and Member CH/194 (Biological Evaluation of Medical Devices).
Dr. Bowness holds a Bachelor of Science (with honours) degree in biomedical sciences specializing in medical biochemistry from the University of Bradford. He received an MPhil and PhD in molecular genetics from the University of Newcastle upon Tyne.
Dr. Bowness is a certified risk management professional from the UK Government Office of Government Commerce and certified project manager including PRINCE2 from the Association for Project Management and is a certified professional coach from the Institute of Leadership and Management.
Extensive experience in regulatory compliance and operational delivery of conformity assessments and certification for surgical implants, surgical instruments, devices introducing substances to the body, IVF/ART instruments and media and devices utilizing materials of human/animal/biological origin, including consultations under Regulation (EU) 722/2012 for EU CE and UKCA.
Tutor, MSc Regulatory Affairs (Cranfield University and University of Hereford / TOPRA) and industry tutor - risk management to ISO 14971 and MDD/MDR and devices utilizing materials of animal origin.
Overview
With extensive knowledge of EU Notified Body and UK Approved Body operations including application, submission, conformity assessment, audit and decision making under EU and UK medical device legislation, Dr. Bowness focuses on EU/UK regulation, technical standards and Notified Body interactions, specializing in soft tissue reconstruction, guided tissue regeneration and associated implants and instruments.