Quality Assurance

Digitally store Quality Control and Compliance records, keeping traceability of each device through UDI identification. Secure data with E2E encryption on a blockchain tamper-proof platform.

PMS Data Management

Keep track of product complaint to UDI level. Achieve compliance with MDR regulation and manufacturer obligation of Chapter VII and quickly generate documentation required by Annex III, such as PMS plan, PSUR, PMCF.

Supply chain traceability

Use our platform to model and control your supply chain. Close gaps along the process and integrate with hardware and software tools. Make the information reliable and tamper-proof with our blockchain backbone.

e-IFU

Minimize efforts to manage IFU documentation and share. Easily give access to all relevant users and manage different translations and versions via our cloud solution. Track down IFU to a specific device via UDI identification.

EUDAMED Ready

Use our platform to communicate, load and update all information requested by MDR Chapter III and Eudamed requirements. Streamline the process and minimize regulatory burdens via a predefined interface.

MDR Compliance

Use our tool to achieve and prove MDR compliance. Easily collect and review data to support device safety and efficacy.