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…
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…
Valerie Borg
Business Administrator (Malta)
Born and raised in Australia and now enjoying a new lifestyle in Malta. Has over 20 years of experience in…