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white paper

Efficient medical device delivery with a closed-loop quality management system

Pulse oximeter clip on finger with Siemens branding in background
Medical device & diagnostics (MD&D) companies frequently face challenges in managing new technologies amid complex regulations. These structures often shift focus from product quality to compliance documentation. Medical device manufacturers can implement a closed-loop quality and compliance program supported by a flexible quality management system (QMS) to accelerate product development and reduce time-to-market. This ensures a priority on device performance and patient safety, seamlessly integrating documentation.

Read the white paper to learn how to advance in the medical device market.

Developing a closed-loop quality roadmap

MD&D companies strive for continuous, real-time compliance with regulations, ensuring product quality for patient safety. A closed-loop quality roadmap facilitates this through two steps. First, it transforms the competitive dynamic between quality and compliance into a complementary relationship. This comprehensive approach integrates compliance into outcomes, allowing the product development team to concentrate on quality while the Quality Management System (QMS) handles standards. The second step emphasizes achieving transparency by transitioning from technical silos to digital connectivity, utilizing an integrated digital platform that streamlines regulatory management, accelerating compliance for market submissions and supporting continuous quality improvement in medical devices.

Read the white paper and learn more about how a closed-loop quality approach can accelerate compliance for market submissions and achieve continual quality improvement for medical devices.

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