The Regulatory Affairs Software for Medtech and IVD companies
REGULA™ is a database backed application for an efficient management and reporting of worldwide medical device and in vitro diagnostic device regulatory affairs activities. The application is developed, maintained and validated according to ISO 13485 and IEC 62304 standards.
REGULA™ has been developed by RA practitioners for RA practitioners with dedication to regulatory affairs. REGULA™ is not just a software because there is a lot of RA expertise integrated in the application.
The goal of REGULA™ is to reduce your „time to market" and increase the efficiency in the daily RA business.