Affix Compliance Ltd
Country headquarter:
UK.
Market presence:
UK and Spain.
General description:
Laura Magaña, founder and Regulatory Affairs Compliance Director, has gained over 20 years of experience and a broad expertise leading compliance in small, medium and large size companies. Our area of expertise ranges from medical devices, ‘in vitro’ diagnostic medical devices (IVDs) and health & food safety to animal health, cosmetics and digital health industries. In addition, she has led and successfully delivered both face-to-face and e-learning courses for professionals.
Areas of regulatory/reimbursement support:
Affix Compliance provides project management and regulatory support services for CE Marking, Regulatory Affairs, Audits, QA/RA compliance, Vigilance and Post-market surveillance, Software Qualification and classification and Training.
https://ec.europa.eu/digital-single-market/en/ehealth-and-ageing
The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.