How Qualityze QMS Powers Quality and Compliance in the Medical Device Industry:
Enhance Patient Safety with In-Built Risk Management
Leverage configurable workflows to align risk management capabilities with ISO 14971. It helps proactively identify, assess, and mitigate risks throughout production. Our solution integrates risk thresholds, evaluation criteria, and response mechanisms to ensure patient safety and regulatory compliance.
Proactively Manage Post-Market Surveillance (PMS)
Stay ahead in regulatory reporting with centralized post-market surveillance tools. Our QMS facilitates adverse event reporting, recall management, and trend analysis, ensuring compliance with FDA and EU vigilance requirements to maintain product safety and quality.
Optimize Supply Chain Quality and Traceability
Ensure supplier compliance and traceability across the medical device supply chain with our integrated supplier quality module. Manage approved supplier lists, scorecards, and supplier risks while complying with global UDI mandates for enhanced traceability.
Streamline Regulatory Compliance Across Global Markets
Our QMS simplifies adherence to complex regulations such as FDA 21 CFR Part 820, EU MDR/IVDR, and ISO 13485. With pre-configured workflows, automated reporting, and real-time tracking, it ensures seamless compliance across diverse regulatory landscapes while reducing the burden of documentation.
Secure Device Interoperability and Cybersecurity
Address the growing challenges of device connectivity with built-in security controls and compliance workflows for IEC 62304 and ISO/IEC 27001. Our solution supports secure data exchange and real-time monitoring to mitigate cybersecurity risks.
Maintain Comprehensive Adverse Event Reporting Systems
Easily capture, track, and report adverse events with our integrated QMS, ensuring compliance with FDA eMDR and EU vigilance system requirements. Our solution helps generate HL7 compliant xml files for eMDR submissions. Our pre-defined workflows streamline investigations and prevent recurrence effectively.
