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Medical Device Industry - Business Challenges

Medical device engineering teams using PTC Integrity achieve and streamline compliance, improve productivity and quality, and gain complete product visibility. PTC Integrity provides medical device engineering organizations with the ability to reduce the overwhelming complexity of developing software intensive products, which ultimately drives more innovative products into the market.

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Most Commonly Reported Challenges in Medical Device Engineering:

  • Achieving and demonstrating compliance to standards such as ISO 14971 and IEC 62304 and FDA and CE Mark Regulatory Requirements is costly, time consuming, and error prone
  • Implementation of a compliant Quality Management System to satisfy the FDA ruling classifying an MDDS as a Class 1 device
  • Lack of visibility into product quality measures and readiness milestones can result in poorly informed decisions and affect investor confidence
  • Software is increasingly vital to product design and differentiation, but its growing volume and complexity is difficult to manage
  • Management of multiple variants of products for different markets and opportunities is complex and error prone

 

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The PTC Integrity solution for medical device engineering companies:

  • Demonstrates compliance in minutes with automated report generation rather than the weeks required with manual processes
  • Integrates Risk Management, Requirements Management, Design, Verification and Validation seamlessly, enabling mouse-click change impact analysis
  • Provides a scalable and flexible solution tailored to manage the volume and velocity of software driven change in the medical device industry
  • Reduces development time and costs while improving product quality with its collaborative development environment, true asset re-use capabilities, and on-demand and real-time visibility into product quality and milestone metrics

 

For more videos on the PTC Integrity solution for Medical Device Engineering companies click here

 

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Reducing Manual Effort for Risk Management Compliance