What is IVDR and how does it affect labeling and artwork management?
Navigate the complexities of the In Vitro Diagnostic Regulation (IVDR) with Kallik’s advanced labeling and artwork management solutions. Designed specifically for in vitro diagnostic manufacturers, our intuitive software streamlines the creation of compliant labels, ensuring accuracy and adherence to stringent regulatory requirements.
With powerful automation, seamless approval workflows, and comprehensive version control, Kallik’s software simplifies the labeling process, helping you meet the high standards of the IVDR while reducing errors and accelerating your time to market. Enhance product safety, maintain traceability, and confidently scale your in vitro diagnostics business with Kallik’s trusted solutions.
What is IVDR?
The In Vitro Diagnostic Regulation (IVDR) is a set of European Union regulations that governs the production and commercialization of in vitro diagnostic medical devices. It aims to improve the safety, transparency, and performance of these devices by setting more rigorous requirements for their clinical evaluation, risk management, and post-market surveillance.