A senior Consultant with over 9 years in medical devices industry working on airways, COPD, IVF and ventilator devices. Responsible for providing regulatory consultancy to clients seeking to obtain or maintain CE marking for a broad range of medical devices (MDD Classes I, IIa, IIb and III). Review and collate Technical files including Clinical Evaluation Report to MEDDEV 2.7.1 rev 4, Risk Management to ISO14971 and post market surveillance plans/reports. Assist clients with ISO13485 related activities including Quality Systems gap analyses, procedures and internal audits. Qualified Analytical Chemist with 12 years R&D Pharmaceutical experience.
Helen George
Business and Project Manager
Helen joins Advena as our Business and Project Manager. She has over 6 years in the medical device industry experience…
Andrea Thomas
Regulatory Consultant
A regulatory consultant with an MSc in Medical Statistics with Health Technology Assessment. Experienced in FDA submissions, compilation of CE…
Anthony Kirby
Managing Director – Advena Limited (Malta)
In excess of 20 years experience in Business Management, Systems & Procedures. Wide-ranging experience in the Medical Device Industry and…