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Fully Validated QMS Software

Medical Device QMS: Compliance & Quality Made Easier

Meet ISO 13485, FDA 21 CFR Part 820 and EU MDR regulations with QT9’s fully validated cloud QMS built for medical device manufacturers. Automate audits, traceability and compliance from design to post‑market.

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Medical Device QMS Software
Centralized Document Control
Automated Training Compliance
FDA & ISO Ready
Integrated CAPA & Audits

Top challenges in medical device quality management

Medical device manufacturers face unique compliance pressures. Here are four common pain points that slow teams down — and how QT9 QMS helps solve them.

Audit Stress

Preparing for FDA or ISO audits can take weeks when records are scattered.

Manual Processes

Spreadsheets and paper tracking waste time and increase the risk of errors.

Traceability Gaps

Linking design inputs, production, and post-market complaints is slow without the right system.

Multi-Site Challenges

Inconsistent processes across facilities create compliance risks and delays.

Why medical device teams choose QT9 QMS

See how our system compares side by side — replacing manual processes with automation, and turning compliance challenges into advantages.

Challenge
Without QT9 QMS
With QT9 QMS
Document Control
Multiple versions and manual tracking
One system with automated approvals, version control and always audit-ready docs
CAPA & Nonconformances
Weeks of digging through records to find root cause
Root cause found in hours, with all actions tracked and logged in real time
Audit and Compliance Readiness
Scattered files, stressful audit prep
Centralized dashboards, real-time audit trails, inspection-ready anytime
Electronic Device History Records (eDHRs)
Paper-based DHRs that are error-prone and slow
Automated eDHRs with full traceability, compliant with FDA 21 CFR Part 820
Training Management
Hard to track staff training and certifications
Automated training records with reminders, ensuring ongoing compliance
Website-Med-Device-Page-1000x667

End-to-end quality automation for medical devices

  • Streamline document control with Part 11-compliant e-signatures

  • Automate change control, CAPA and NC tracking

  • Manage training assignments and certifications with ease

  • Generate audit-ready reports in seconds

  • Ensure traceability from design to production

  • Simplify supplier management and quality audits

Why QMS matters

A modern Quality Management System is more than a compliance tool — it’s the foundation for safer products, stronger teams, and long-term business growth.

  • Build trust & reduce risk with integrated traceability and audit-ready documentation

  • Boost cross-functional quality by digitizing workflows across design, production, and suppliers

  • Improve operational efficiency with centralized processes and real-time reporting

  • Go beyond compliance — use ISO 13485 as a driver for continuous improvement and innovation

  • Be prepared for growth by scaling seamlessly from small teams to global medical device enterprises

Key features for medical device manufacturers

Document Control

Maintain full version control and electronic approvals.

Document Control

Design Control

Track design history files (DHFs) and design inputs/outputs.

Design Control

CAPA Management

Streamline corrective and preventive actions with automated workflows.

CAPA Management

Employee Training

Assign and verify training with electronic tracking and reminders.

Employee Training

Change Management

Control and document all changes with complete traceability.
Change Management

Audit Management

Plan, execute and document internal and external audits.

Audit Management

Risk Management

Track risk using built-in risk management tools

Risk Management

Complaint Handling

Log, investigate and close complaints faster with built-in escalation.

Complaint Handling

Supplier Quality

Evaluate and track supplier performance in real time.

Supplier Quality
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ISO 13485

Achieve ISO 13485 Compliance with Centralized Quality Management

  • Centralize all feedback for easy access and resolution
  • Link corrective actions directly to complaints & NCRs
  • Launch investigations in one click from any record
  • Generate audit-ready reports in real time
Explore ISO 13485

medical-device-qms-software

Simplify FDA 21 CFR Part 820 Compliance with Integrated Controls

  • Centralize QSR documentation and approvals 
  • Automate CAPA and complaint workflows 
  • Track inspections, calibrations and audits
  • Ensure validation and traceability
Explore FDA 21 CFR Part 820

Design-traceability

Maintain Complete Design Traceability from Concept to Compliance

  • Track DHFs, inputs and outputs and  in one place 
  • Automate design approvals and signoffs
  • Maintain audit-ready design records 
  • Ensure ISO 13485 compliance
Explore Design Control

Process-control-on-laptop

Connect Production Data and Process Control for Total Visibility

  • Capture inspections and calibration results 
  • Link process data to batch records (ERP)
  • Monitor equipment maintenance status 
  • Improve production consistency
Explore Inspection Module

Risk-and-CAPA-software

Manage Risk Management and CAPA to Eliminate Quality Issues

  • Link to NCs, CAPA and complaints
  • Track root causes and preventive actions 
  • Score and review risk severity trends 
  • Prevent repeat quality issues 
Explore CAPA Module

QMS supplier Module

Centralize Supplier Oversight and Purchasing Quality Controls

  • Approve and rate suppliers centrally 
  • Track audits and corrective actions 
  • Monitor supplier certifications 
  • Meet ISO 13485 clause 7.4
Explore Supplier Web-Portal

Global Scalability

Drive Continuous Quality Improvement Across Global Operations

  • Multi-site deployment with shared access
  • Meet ISO 13485, EU MDR, FDA, and MHRA requirements
  • Centralize records across regions and facilities
  • Scale easily from small teams to enterprise operations
  • Provide real-time visibility for global leadership

 

Explore Platform

Built to support international medical device compliance

FDA 21 CFR Part 820 Compliance

FDA 21 CFR Part 820

U.S. quality system regulation for medical device manufacturing and distribution

FDA 21 CFR Part 820
ISO 13485 Compliance

ISO 13485

International quality management criteria for medical device manufacturers

ISO 13485
FDA 21 CFR Part1 11 Compliance

FDA 21 CFR Part 11

U.S. regulations for electronic records and signatures

FDA 21 CFR Part 11
EU-MDR-Compliance

EU MDR

European Union Medical Device Regulation

EU MDR
PIC/s Compliance

PIC/s

Pharmaceutical Inspection Co-operation Scheme

PIC/s
Validated-QMS-Software-900x900

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

Why choose a pre-validated QMS?

  • FDA and ISO compliance out-of-the-box

  • Rapid cloud deployment for faster implementation

  • Audit-ready with timeline traceability 

  • Electronic signature approvals and secure access controls

  • Continuous validation and updates

What compliance standards need validation?

• ISO 13585
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance
Is IQ, OQ, PQ part of validation?

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

How does pre-validated QMS software save money?

  • Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.

  • Reduces downtime waiting for your QMS to be approved for use.

  • Minimizes the risk of any failed audits due to flawed validation protocols.

Schedule a Demo

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

 

FAQ: Medical Device QMS

What is a medical device QMS?

A medical device quality management system (QMS) is a formalized set of business processes that documents the policies and procedures a medical device company must use to ensure their products are safe, effective and in compliance with all applicable regulations and standards.

What is medical device QMS software (eQMS)?

Medical device QMS software automates quality management processes and documentation and unites them into one, dedicated and integrated software solution that affords greater productivity and collaboration. A medical device eQMS improves the overall efficiency of operations by providing a built-in framework for quality and compliance where tasks are automated, data is available in real time, and controls are easily managed.

What are the benefits of implementing a medical device QMS?

With QMS software, medical device development, design and manufacturing quality management processes are completely automated and connected, reducing the opportunity for human error and keeping quality tasks on track. QMS software is geared toward compliance, making necessary compliance tasks a part of everyday work. Some of the features of medical device QMS software include:

  • Document Control
  • Design Management
  • Change Control
  • Customer Complaints
  • Audit Management
  • Engineering Changes
  • Employee Training
  • CAPA/Nonconforming Products
  • Supplier Management

QMS software provides efficiencies that help your business work smarter, such as automated document management with electronic signatures, built-in traceability, task and scheduling reminders, and access at any time, from anywhere

What are the key regulations a medical device QMS should address?

Medical device companies are required to adhere to strict laws, regulations and standards. The International Organization for Standardization (ISO) has established standards that medical device companies must follow. ISO 13485: 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The Food and Drug Administration (FDA) has established current good manufacturing practice (cGMP) requirements for medical device quality management systems in the United States. FDA 21 CFR Part 820 requirements, also known as Quality System Regulation (QSR) detail the requirements of the quality management system for medical device companies.

Beginning February 2, 2026, the U.S. FDA requirements for medical device quality management systems will more closely align with the international consensus standard for Quality Management Systems for medical devices (ISO 13485) used by many other regulatory authorities around the world. The revised FDA 21 CFR Part 820 requirements are called the Quality Management System Regulation (QMSR).

Why choose QT9 to automate your medical device QMS processes?

QT9 QMS offers an end-to-end solution for addressing the challenges of compliance and quality management in the medical device industry. QT9 QMS offers more than 25 modules that come standard, including:

  • Document Control
  • Risk Management
  • Audit Management
  • Employee Training
  • Supplier Management
  • Customer Feedback
  • Product Design Controls

QT9 also offers the ability for medical device companies to create electronic Device History Records (eDHR) and Device Master Records (eDMR) with one click using a simple QT9 QMS and QT9 ERP integration. Take advantage of QT9’s free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors.

QT9 QMS is a fully validated, highly rated eQMS that is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool. QT9’s user-friendly interface and no-nonsense licensing lets medical device companies focus on getting quality, life-changing products to market faster.

Why medical device companies choose QT9

"All of our records are now in one location"
QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process.
Jennifer B.
Medical Device Industry
Small-Business (11-50 emp.)
"Looking forward to using more modules"
The document control feature has improved our ability to find documents and some records when requested for audit or project purposes. Training is much easier to manage. I like being able to link equipment and gages to system documentation in the Document list. The customer service has always been helpful and responds quickly.
Bill C.
Medical Device Industry
Mid-Market (51-200 emp.)
"Excellent support, traceability and ease of use."
We are a medical device company and myself, the FDA & ISO auditors liked the traceability, control of documents and everything was there at our fingertips from Management review to Documents to CAR's. QT9 is always responsive to our questions and resolving issues. For the cost, the flexibility, electronic signature and traceability is worth trying out the system.
Reba D.
Medical Device Industry
Director of QA/RA

Explore QMS resources

FDA QMSR 2026: Guide to the New 21 CFR 820
Complete guide to helping medical device manufacturers be prepared for QMSR 2026.
Medical Device

FDA QMSR 2026: Guide to the New 21 CFR 820

August 26, 2025 9 min read
From Concept to Market: FDA Approval Process for Medical Devices
Medical Device

From Concept to Market: FDA Approval Process for Medical Devices

November 04, 2024 6 min read
Boost Medical Device Development with Design Control Software
Medical Device

Boost Medical Device Development with Design Control Software

May 21, 2024 6 min read

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