Address
Eversfield Regulatory Limited,
77 Bohemia Road,
St. Leonards-On-Sea,
East Sussex,
England,
TN37 6RJ
Work Hours
Monday to Friday: 9AM - 5PM
What We Do
A summary of our bespoke services:
Quality Management System (QMS)
Setup and Support of your Quality Management System including compliance with the ISO 9001 and ISO 13485 standards
Information Security Management System (ISMS)
Setup and Support of your Information Security Management System including compliance with the ISO 27001 standard
Software Medical Device Design & Development
Project management of Software/A.I. Medical Device development including compliance with ISO 13485, IEC 62304, ISO 14961, IEC 62366
Regulatory Support
Support with Software/A.I. Medical Device market clearances including UKCA, CE Mark, and FDA 510k
Risk Management
Support with your corporate risk management activities, including compliance with popular ISO standards including ISO 27001 and ISO 14971
Information Governance
Support with GDPR / UK DPA 2018 compliance with a focus on A.I.