Manage regulatory compliance through the product lifecycle.
Innovation, Compliance, and Lean Product Development
Medical Device companies operate in a complex regulatory environment demanding collaboration and integration when it comes to product development. Manufacturers are very often limited by legacy PLM, standalone databases and other silos of information to track device master records, design history files, engineering change orders, CAPA and project data. With limited connections and transparency, key product data information is often manually interchanged resulting in lack of agility, and a costly and ever increasing administrative overhead
Today’s PLM for Compliance, Requirements
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
Medical Device companies use Aras PLM 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