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.
Grishma Mistry
Trainee Regulatory Associate
After completing her Internship at Advena, Grishma obtained an MEng in Biomedical Engineering. She continues to support the Consultancy team…
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…
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…