Patricia Byrne

Trisha has worked in regulatory affairs since 2008 and has 13 years’ experience in Regulatory Affairs, specifically in the medical device industry.

She has worked for numerous medical device manufacturers both in Europe and the US, covering a vast array of medical devices portfolios, from breast implants, obesity products, wound care, acute care, patient care and orthopaedic products.

Trisha has also had considerable experience in the development and maintenance of technical files for medical devices, including ERC, GSPR and the coordination of CERs, in addition to the participation of internal and notified body audits for ISO 13485, MDSAP and the Medical Device Directive.

In her previous positions, Trisha specialised in European Regulatory Affairs, CE marking a diverse range of medical devices, from Class I through to Class III, in addition to completing regulatory submission in various international markets.