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.
Andrea Thomas
Regulatory Consultant
A regulatory consultant with an MSc in Medical Statistics with Health Technology Assessment. Experienced in FDA submissions, compilation of CE…
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…
Jessica Ostle
Business Administrator (Jnr)
Jessica joins Advena as Business Administrator (Jnr) after recently graduating with a BA(Hons) in Business and Finance. Her specific role…