Complete MDSAP Compliance Solution for Medical Device Manufacturing
QT9 QMS delivers end to end MDSAP compliance by covering quality system controls, risk management, CAPA, documentation, and audit readiness while integrated ERP capabilities connect manufacturing, inventory and operational data within a single platform.
MDSAP Audit Readiness
Maintain audit-ready evidence, records, and traceability aligned with the MDSAP Audit Model.
CAPA & Nonconformities
Capture issues, investigate root cause, and track corrective actions through verification and closure.
Risk & Change Control
Connect risk management, change control, and quality events to support lifecycle compliance.
Complaints & Quality Events
Track complaints, quality events, and related actions with clear documentation and accountability.
How QT9 Streamlines MDSAP Audit Readiness
QT9 QMS simplifies quality system management, enhances end-to-end traceability, and supports continuous audit readiness, with QT9 ERP providing connected manufacturing and operational data to meet global MDSAP requirements.
QT9 QMS is built for regulated life sciences manufacturers
Streamlined document control
Closed-Loop CAPA & Deviation Tracking
Capture issues as they occur, assign investigations, and verify effectiveness, all within one platform. Every step is traceable, transparent, and audit-ready.
Integrated Workflows Across All Elements
QT9 connects all MDSAP elements through intelligent workflows that mirror your actual quality processes. When a non-conformance is identified, it automatically triggers CAPA, notifies relevant personnel, links to affected documents, and may initiate change control—all within one system. This integration eliminates duplicate data entry, ensures consistency, and provides complete traceability from root cause to corrective action effectiveness.
Simplified Audit & Inspection Readiness
Organize all audit records in one place. Schedule inspections, record findings, and link follow-up actions to demonstrate ongoing MDSAP compliance.
Automated Audit Trails
QT9 automatically captures and timestamps every action within the system, creating comprehensive, tamper-proof audit trails that meet 21 CFR Part 11 and MDSAP documentation requirements. Every document revision, approval, training completion, CAPA update, and change control action is recorded with user identification and reason codes. During inspections, you can instantly demonstrate complete traceability of quality events and decisions across your entire operation—reducing inspection time and increasing auditor confidence.
Real-Time Compliance Dashboards
Monitor your PIC/S compliance status across all 17 elements from a single screen. QT9's intuitive dashboards provide instant visibility into overdue CAPAs, pending document reviews, upcoming calibrations, training requirements, and audit findings. Color-coded alerts highlight areas requiring immediate attention, while trend analysis helps identify systemic issues before they become inspection findings. When an inspection is scheduled, you'll know exactly where you stand.
See how QT9 QMS and QT9 ERP stack up against MDSAP requirements
QT9 is available in the cloud or on-premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
Pre-validated QMS software
QT9 QMS is pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13485 |
• FDA 21 CFR Part 11 |
QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
FAQ: MDSAP
MDSAP compliance means a medical device manufacturer’s quality management system meets the requirements of the Medical Device Single Audit Program, which allows one audit to satisfy multiple regulatory authorities.
MDSAP participating regulatory authorities include the United States (FDA), Canada (Health Canada), Australia (TGA), Brazil (ANVISA), and Japan (MHLW/PMDA).
MDSAP is required for certain manufacturers selling medical devices in Canada, and it is accepted as an alternative to FDA routine inspections in the United States. Requirements may vary depending on market and device classification.
ISO 13485 is a quality management standard for medical devices, while MDSAP is an audit program that includes ISO 13485 requirements plus additional regulatory requirements from participating countries.
An MDSAP audit evaluates key processes such as management responsibility, design and development, production controls, CAPA, complaint handling, purchasing controls, and adverse event reporting.
QT9 QMS helps medical device manufacturers manage document control, CAPA, change control, training, audits, supplier quality, and traceability in one system, while QT9 ERP connects manufacturing, inventory, and operational data, supporting continuous MDSAP audit readiness.
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