ISO 13485

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

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.

Optimize quality management in medical devices with software

Automation of quality processes

Automate different quality-related processes, such as change control, non-conformity management, equipment calibration and employee training for greater operational efficiency, optimized time and effort and improved product quality.
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Document and records management

Simplify the process of creating, revising, approving and controlling documents and records required by ISO 13485 in a centralized manner, ensuring compliance and traceability.
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Product and component traceability

Monitor the complete history of each product and component from conception to delivery to the customer, facilitating the rapid identification of problems and corrective actions, ensuring product safety and quality.
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Why do customers choose SoftExpert

Success Case
União Química manages more than 3,000 documents in SoftExpert Suite and increased its productivity in content management by 30%
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Success Case
CSN Paraná optimizes indicator management and reduces time, gaining 42 days per year in efficiency
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Success Case
Dos Pinos centralizes 186 services with SoftExpert Suite and saves over 30% by implementing a Shared Services Center (SSC)
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Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance

Enterprise Content - ECM
Product Lifecycle - PLM
Enterprise Quality - EQM
Supplier Lifecycle - SLM
Project and Portfolio - PPM

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.

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Product Lifecycle - PLM

Manage your products’ entire lifecycle with a cloud-based solution powered by Gen AI. SoftExpert PLM accelerates time-to-market, automates repetitive tasks, and delivers intelligent insights for strategic decisions. Improve quality, reduce costs, and optimize resources with a secure, scalable, and innovative platform.

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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.

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Supplier Lifecycle - SLM

Manage the full supplier lifecycle with a cloud-based solution enhanced by Gen AI. SoftExpert SLM automates processes, qualifies partners, ensures compliance, and reduces risks with real-time insights. Boost performance visibility, efficiency, and trust with a secure, intelligent, and scalable platform.

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Project and Portfolio - PPM

Transform your project and portfolio management with a complete, cloud-based, AI-powered solution aligned with PMBOK. Connect planning, execution, and monitoring through intelligent automation and real-time insights to ensure on-time delivery with quality and high performance.

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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.

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

ISO 13485

International standard for quality management systems in medical devices.

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