Drive Innovation, Manage Risk and Compliance, and Achieve Lean Product Development

Medical Devices Industry Status

Medical Device companies are under extraordinary pressure to increase profits, reduce risk and meet the demand for innovation while managing fierce global competition, increased regulation and ever-shrinking product development cycles.

Today’s PLM for Compliance, Requirements

Medical Devices

Read a timely white paper showcasing next generation integrated requirements management

Benefit from a new approach to regulatory compliance, efficient document management, effective collaboration across disciplines and other mission-critical challenges. Aras Innovator helps the industry work more effectively, reduce time-to-market and ensure regulatory compliance.

Today’s leading medical device companies streamline compliance by integrating regulations into product development and throughout design. From project management and integrated requirements to traceability and reporting, leading companies address key challenges with flexible, scalable and upgradeable PLM.

The Aras Value for Medical Devices

We've developed solutions specifically for Medical Device companies to drive quality and innovation, reduce risk and manage regulatory compliance.

  • Best Practices for Global Product Development, including Design History Files (DHF) and Device Master Records (DMR), Audit Compliance, Corrective Actions, Enterprise Change Management, and Verification and Validation
  • Standards, Quality, Safety and Regulatory Compliance, including Lean, FEMA, CAPA, 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11 Compliance, ISO 13485, the European MDD (2007/47/EC) and Support for Class 1 ,2 & 3 Devices
  • Business Intelligence and Analytics, including Reports, Scorecards, Dashboards and KPI Metrics
  • Flexible, Easy to Use Web-based Environment with Intuitive Microsoft Look and Feel

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