ISO 13485
Manage documents, quality control activities and process monitoring, ensuring the safety and effectiveness of medical devices with SoftExpert Suite.
Optimize quality management in medical devices with software
Automation of quality processes
Document and records management
Product and component traceability
Bring this solution to your company
Why do customers choose SoftExpert
União Química
CSN Paraná
Dos Pinos
Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance
Enterprise Content - ECM
SoftExpert ECM is a comprehensive enterprise content management software solution that centralizes all organizational content. It allows you to create, capture, manage, store, preserve and share documents and records, reducing paperwork and related deviations. The ECM solution ensures security, integrity, reliability, and compliance with international standards such as ISO 9001 and FDA 21 CFR Part 11.
Product Lifecycle - PLM
Manage your products’ entire lifecycle with a cloud-based solution enhanced by Gen AI. SoftExpert PLM leverages generative AI and cloud technology to streamline product development — from concept to launch. Accelerate time-to-market, automate repetitive tasks, and make smarter decisions with intelligent insights. Improve quality, reduce costs, and boost efficiency across every stage of the lifecycle with a scalable, secure digital platform.
Enterprise Quality - EQM
Modernize your quality management system (QMS) with an all-in-one solution. Reduce the effort to stay compliant, increase process agility, and gain transparency to drive continuous improvement with more control and efficiency.
Supplier Lifecycle - SLM
Manage the full lifecycle with a robust, integrated solution that automates processes, qualifies partners, ensures compliance, reduces risks, and provides full performance visibility to boost efficiency and trust across the supply chain.
Project and Portfolio - PPM
Transform your project and portfolio management with a complete, integrated solution aligned with PMBOK, connecting planning, execution, and monitoring to ensure on-time delivery with quality and high performance.
Compliance with global privacy and security standards
Advanced data protection
SoftExpert ensures the protection of your company's data and compliance with the requirements of the latest standards.
Integrate with your ERP, CRM, Office365, and much more
Connect SoftExpert Suite to other business tools already used in your organization.
Worldwide Office Locations
Supporting and implementing your growth and expasion everywhere! We are present locally, ready to ensure that SoftExpert solutions are working without limits.
Customize the solution to your needs
Add new modules to your product, customize your experience and get all the solutions you need for your company.
Glossary
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