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.
Kenneth Shaw
Lead Regulatory Consultant (Malta)
A medical device regulatory consultant with a biomedical and mechanical engineering background experienced in the creation and review of technical…
Sarah Pavitt
Senior Regulatory & Quality Consultant
A senior Consultant with over 9 years in medical devices industry working on airways, COPD, IVF and ventilator devices. Responsible…
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…