A Medical Device consultant with extensive experience of both regulatory and quality projects in accordance with both European and United States standards. Previous experience with Neurological, Orthopaedic, Contraceptive Device and Procedure Pack devices, compiling both CE Technical Files, Design Dossiers and 510 (k) submissions (k) for US market as well as submissions for Australia, New Zealand, Canada and Japan.
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…
Grishma Mistry
Regulatory Consultant
After completing her Internship at Advena, Grishma obtained an MEng in Biomedical Engineering. She continues to support the Consultancy team…
Roxana Coltan
Business Administrator (UKRP)
Roxana joins Advena as our UKRP Business Administrator. Roxana is an experienced Business Administrator with over six years’ experience in…