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 The Only ERP Built and Pre-Validated for Medical Device Manufacturers 

DHR, DHF and DMR maintained automatically — with audit trails, electronic signatures and QMSR support built in from day one.

FDA 21 CFR Part 820 / QMSR
FDA 21 CFR Part 11
ISO 13485
EU MDR
MDSAP
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Pre-Validated ERP, No Internal CSV Required

QT9 ERP arrives fully validated — IQ/OQ/PQ included — so your team can focus on manufacturing, not documentation. Built-in support for 21 CFR Part 11, with audit trails and electronic signatures ready on day one.

  • Faster Implementation: Validation documentation included, not a separate project
  • Reduced Compliance Burden: No internal CSV effort required
  • 21 CFR Part 11 Support: Electronic signatures and audit trails built in
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Medical-Device-ERP
Medical Device ERP Software

Medical Device Files (DHR, DHF, DMR) are Automatically Maintained

  • DHR: Automatically built in real time from production activity — no manual assembly before release 
  • DHF: Design control workflows link risk, verification, validation and change history in one place 
  • DMR: Specifications, drawings and approved processes stay synchronized with active production 

When Quality and Operations Share a Brain, Everything Changes

Standard
How QT9 ERP Addresses It
ISO 13485:2016
End-to-end QMS integration with document control, CAPA, risk, training and audit management
FDA 21 CFR Part 820 / QMSR
Full support for design controls, production controls, traceability and compliant handling
FDA 21 CFR Part 11
Secure electronic signatures, audit trails and system validation included
EU MDR
Device traceability, UDI readiness, technical documentation and post-market surveillance workflows
Risk Management
Integrated risk analysis tied directly to design, production and CAPA workflows

QMSR-Ready on Day One

The FDA's Quality Management System Regulation (QMSR), effective February 2024, aligns 21 CFR Part 820 with ISO 13485:2016 — changing documentation requirements, design control expectations and quality system structure for every US medical device manufacturer.

QT9 ERP is already aligned with QMSR. There's no transition project, no gap assessment to reconcile, and no additional validation work required. If you're mid-transition or evaluating systems before committing to a path, QT9 removes the regulatory uncertainty from your ERP decision entirely.

  • Meets updated design control and production control requirements under QMSR
  • ISO 13485:2016 alignment built into quality workflows — not bolted on
  • Pre-validated platform means your QMSR compliance posture is established at go-live
Estimate Your Hidden Cost of Poor Quality

What Is Poor Quality Costing Your Business Each Year?

Answer a few quick questions to estimate the potential annual cost of scrap, rework, holds, supplier issues, and investigation delays.

Complete all inputs to unlock your estimated annual COPQ (0/7)

 Want a More Detailed COPQ Estimate? 

 Get access to our advanced calculator for a deeper, personalized analysis of what poor quality is costing your operation.

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See What Industry Leaders Say About QT9 ERP

"Working in Class II medical devices it is important to use a validated system, QT9 checks this box at no additional cost. Another great feature is the synchronization with the QT9 QMS. Job module and electronic DHR are a must-have and QT9 does it right. The compliance module is great, especially during audits. "
Sorin G | Lead Manufacturing | Medical Devices
G2 Review
"Having been involved in a number of ERP integration projects throughout my career, I had some anxiety when the project commenced. However, the integration team quickly put my mind at ease."
Bob F | VP, Quality | Medical Devices
Capterra Review
“QT9 ERP is a game changer for our medical device business. Being an FDA regulated and ISO 13485 manufacturer, the integration between QT9's ERP and QMS is a huge advantage, providing full traceability and direct integration between our operations and our quality system."
John S. President | Medical Devices
Capterra Review

Ready to Eliminate Validation Delays and Quality Gaps?

Book a 30-Minute Demo with a Medical Device ERP Specialist.

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