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.
Abigail Psaila
Regulatory Associate (Malta)
Abigail joins Advena as a Regulatory Associate, with a BEng in Electrical Engineering and experience in compiling technical documentation for…
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…
John Adcock
CEO – Advena Ltd (UK & Malta)
30 years experience in global medical device regulatory affairs including the position of Vice President of International Regulatory Affairs with…