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