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…
Anna Galluzzo
Regulatory Consultant (Malta)
A medical device consultant with extensive knowledge of the medical device regulatory field with a PhD, a MSc and a…
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…