Medical Device Solutions
Purpose-built quality management for medical device companies. ISO 13485 compliance, DHF/DMR management, CAPA workflows, risk analysis, and design controls in one integrated platform.
Built for Medical Device Manufacturers
Everything you need for medical device quality and regulatory compliance:
ISO 13485 Compliance
Complete ISO 13485 quality management system with predefined procedures, work instructions, and records tailored for medical device manufacturers.
DHF & DMR Management
Manage Design History Files and Device Master Records with structured templates, automated workflows, and full version control.
CAPA Management
Corrective and Preventive Action workflows with root cause analysis, effectiveness checks, and trending reports for FDA readiness.
Risk Analysis
ISO 14971 risk management with hazard analysis, risk estimation, risk evaluation matrices, and risk control verification tracking.
Validation Workflows
IQ/OQ/PQ validation protocols, test script management, deviation tracking, and validation summary report generation.
Design Controls
FDA 21 CFR 820 design control management with design inputs, outputs, reviews, verification, validation, and transfer tracking.
Why Medical Device Companies Choose GatesFlow
Deliver safe, compliant medical devices with confidence:
Ready for FDA-Ready Quality Management?
Join medical device companies achieving regulatory excellence with GatesFlow's integrated quality platform.