Real Regulatory to attend MEDICA Trade Fair
MEDICA is the world’s largest event for the medical sector. This top-class event attracts several thousand exhibitors from more than 50 countries with attendees from the fields of business, research and politics, alongside national and international experts and decision-makers from the medical device sector.
Our Medical Device Team will be in attendance. Our committed experts specialise in European Regulatory Affairs with a proven track record in all aspects of medical technology understanding the complex regulatory environment for medical devices and providing strategic regulatory support for development activities and CE Marking applications.
We would welcome the opportunity to meet and learn about how your team is navigating the complexities of the EU Medical Device Regulation 2017/745.
To arrange a meeting at a time convenient to you, contact us today.
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. In her previous positions, she 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.
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.
Catherine has worked in Quality Assurance since 1987 then, in 1993, began to focus on Regulatory Affairs for medical devices. She has worked for companies with manufacturing in Europe, US and Asian markets covering many categories of medical device and other product portfolios from orthopaedic implants, first aid and wound care, consumer healthcare and aesthetic devices. CE marking medical devices from Class I through to Class III, cosmetic products, non-medical electrical devices along with completion of regulatory submissions and approvals in many international markets.
Working on all aspects of regulatory device submissions, under both MDD and MDR including product development, product changes, vigilance, post market surveillance, ISO 13485, MDSAP, KGMP, BGMP, Taiwan QSD.