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title: LP | QMS Medical Device
---

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# MEDICAL DEVICE & DIAGNOSTICS

A harmonized framework for managing medical device quality and regulatory compliance.

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Trusted by Companies Worldwide

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The AssurX Medical Device Quality Management System: Aligning Quality Objectives with Compliance Requirements

The medical device market is full of opportunities to create life-saving products that diagnose and treat patients worldwide. AssurX medical device quality management system is designed to support manufacturers in marketing safe and effective medical devices. Additionally, it demonstrates compliance to meet those demands.

Device and diagnostics manufacturers use the AssurX EQMS to bridge the gap between aligning quality processes to improve product safety. They also maintain medical device compliance with applicable regulations.

 

| - Audit Management - CAPA Management - Calibration Management - Change Management - Complaint Management - Customer Quality Management - Deviation Management - Document Management | - EHS Incident Management - Nonconformance Management - Quality Management Review - Risk Management - Supplier Quality Management - Training Management - Validation Management Solution |
| --- | --- |

 

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Ventilator manufacturer Nihon Kohden OrangeMed proactively takes control of quality management and regulatory compliance with powerful workflow processes that form a connected, single source of truth. They scale with AssurX to maximize patient safety and build a strong brand.

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