Qualityze AI-Powered Complaint Management helps medical device organizations capture, assess, investigate, and report complaints in a centralized, closed-loop system aligned with FDA 21 CFR 820, EU MDR, ISO 13485, and global regulatory frameworks.
Centralize Design Controls, DHF, DMR, and DHR in one connected system
Align QMS with 21 CFR 820, EU MDR, ISO 13485 & global standards
Automate ISO 14971 risk management across the product lifecycle
Purpose built for FDA-regulated, ISO-certified,
and GxP-driven medical device enterprises.
Fragmented systems increase regulatory risk. Incomplete DHFs, outdated risk assessments, and disconnected CAPAs raise compliance exposure. Qualityze AI-Powered QMS enforces structured governance across the device lifecycle.
Standardize Design Controls from concept to commercialization
Automate risk-based decision workflows aligned with ISO 14971
Manage Nonconformance and CAPA with enforced root cause validation
Maintain complete traceability from requirement to release
Faster Compliance Audits
Reduction in Non-Conformities
Improvement in Process Efficiency
Customer Satisfaction Rate
Reduction on Operational Costs
Successful Implementation
Lower Defect Rate
Lesser Rework
Experience the Next Generation Quality Management Today!
● All Qualityze Products
Qualityze AI QMS ensures compliance, risk control, and accountability end-to-end.
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Ensure compliant documentation, traceability, and risk alignment with FDA 21 CFR 820 & ISO 13485.
Maintain living risk files linked to design, production, complaints, and CAPA.
Nonconformance, in-process quality controls with enforced workflows.
Qualify and monitor suppliers with risk-based management and audits.
Track field issues, complaints, and adverse events with validated reporting.
