James Pink
James is the Senior Director of global medical technology testing, inspection, and certification for Element RegNav. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access. He has audited hundreds of medical device companies as part of the European CE marking requirements.
Experience
James was a Lead Assessor at BSI for ~5-years between 2001 and 2005 where he specialised in auditing orthopaedic and active medical devices, and approving them to market. He moved on to become BSI’s Global Head of Business Development and Medical Device Training in 2006.
Post-BSI, James founded his own medical technology and combination product consultancy that was acquired by NSF International in 2011. He subsequently spent 10-years at NSF, rising to become the Director of Certification in Ireland, and then the Senior Director of their Health Sciences practice. He joined Element in 2021 to run support Element’s global expertise in medical technology testing, inspection and certification. James is based in our London office, and works on Element RegNav
Career Highlights
- Lead assessor and Technical Manager at BSI for orthopaedic and active medical devices
- Contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards
- Founded and sold a consultancy covering medical technologies and combination products
Qualifications and Credentials
Qualifications
- ISO 7799-2 Certified Auditor
- ISO 9001 Certified Auditor
- ISO 13485 Certified Auditor
- Masters, Computer Science; University of York
- Masters, Mechanical Engineering; University of Sheffield
