A Medical Device consultant with extensive experience of both regulatory and quality projects in accordance with both European and United States standards. Previous experience with Neurological, Orthopaedic, Contraceptive Device and Procedure Pack devices, compiling both CE Technical Files, Design Dossiers and 510 (k) submissions (k) for US market as well as submissions for Australia, New Zealand, Canada and Japan.
James Bradbury
Medical Device Quality Management Consultant/Manager (UK)
James joined Advena as the Medical Device Quality Management Consultant/Manager. He has 25 years broad experience in Quality Assurance and…
Kirsty Ostle
Managing Director – Advena Limited (UK)
Over 15 years’ experience within Medical Device Regulatory, with 10 years of those in Consultancy. Specialising in single use, sterile…
Sarah Pavitt
Senior Regulatory & Quality Consultant
A senior Consultant with over 9 years in medical devices industry working on airways, COPD, IVF and ventilator devices. Responsible…