ISO 13485

Manage documents, quality control activities and process monitoring, ensuring the safety and effectiveness of medical devices with SoftExpert Suite.

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Solve your challenges

Ensure suppliers meet requirements through careful selection, continuous evaluation and monitoring.

Ensure compliance with standard requirements with ongoing monitoring and updated processes and documentation.

Document and manage changes related to processes with security, communication between areas and effectiveness.

A decision capable of changing the game

Large companies in the market have already recognized our global potential and have become our allies.
Your company could be next.

Glossary

ISO 13485

International standard for quality management systems in medical devices.

Codex Alimentarius

A collection of international food standards, guidelines, and codes of practice aimed at promoting food safety, protecting consumer health, and facilitating international food trade by ensuring the harmonization of food regulations and standards worldwide.

EBR (Electronic Batch Record)

A digital system used to record, track, and manage information generated during batch manufacturing, including materials, equipment, operators, process parameters, quality controls, and deviations. EBR replaces paper-based records, improving traceability, data integrity, and compliance with regulatory requirements.

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Secure, compliant, and ready to integrate with your ecosystem

Built to connect with your existing stack while keeping governance, traceability, and control at the center.

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Recognized Platform

An award-winning platform recognized by customers

Trusted by users and rated across leading software review platforms for value, usability, and support.

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Global Thinking with Local Service

SoftExpert's global presence, with operations on every continent, drives its growth by delivering strong, personalized service tailored to each local market.

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