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Electronic Device History Record (eDHR) Software Made Easy

Go paperless and create Device History Records (eDHR) and Device Master Records (eDMR) with one click using QT9 QMS and QT9 ERP software. Master regulatory compliance and ensure the accuracy and integrity of your data with the only eDHR software that seamlessly integrates quality data into DHR processes. Generate single- and multi-level DHRs and DMRs. Take advantage of free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors. 

Modernize device history records 

Streamline your device records

Ensure FDA & ISO compliance

Simplify quality processes

Centralize doc control

Get traceability & accuracy

Access real-time analytics

Get a Demo
Optimize DHR processes
 

DHR compliance made easy for medical device manufacturers

See how QT9 helps medical device manufacturers with Device History Records (DHR) and Device Master Records (DMR).
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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.

1,000+ of the world's leading companies trust QT9

Ensure regulatory compliance 

  • FDA 21 CFR Part 820 and ISO 13485:2016 Compliance: Easily document and trace manufacturing specifics for each lot, batch and unit.

  • cGMP Compliance: Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of medical device production.

  • FDA 21 CFR Part 11 Compliance: Review and electronically approve documents with FDA 21 CFR Part 11-compliant electronic signature approvals.

  • Compliance Portal: Guide FDA auditors to electronic device history records and device master records with print capabilities.
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Optimize eDHR processes

  • Time-Stamped Audit Trail: QT9 automatically stores a timeline of every transaction for traceability.

  • Lot Number or Serial Number Traceability: Track every move from initial purchase to shipping.

  • Manage Expiration Dates: Receive automated alerts for minimum stock levels and soon-to-expire inventory.
     
  • Multi-Location Inventory Tracking:  Integrate data across multiple locations to ensure everyone is connected. 

  • Multilevel DHR/DMR Generation: Generate single-level and multi-level eDHRs and DMRs for the medical device industry in one-click.
Learn About QT9 ERP

Modernize device history records

  • Document Control: Go paperless by centralizing your documents with a cloud-based solution that includes revision-level controls.

  • Barcoded Inventory Control: QT9 makes it easy to utilize barcodes for inventory accuracy and scanning across operations. 
  • Inspection Planning: Automate inspection processes with an easy-to-use cloud-based inspection solution.

  • Attach Related Files: Track certificates of analysis or compliance with unlimited file attachments on inspection records.

  • Real-Time Analytics: Turn data-driven insights into opportunities with real-time interactive dashboards.
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Description
QT9 Module
Subpart (a)
Device Specifications
QT9 ERP Bill of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
Subpart (b)
Process Specifications
QT9 ERP Bill of Materials / QT9 QMS Inspection Plans / QT9 QMS Documents
Subpart (c)
Quality Assurance Procedures and Specifications
QT9 QMS Documents / QT9 QMS Inspection Plans
Subpart (d)
Packaging and Labeling Specifications
QT9 QMS Documents / QT9 ERP Bill of Material File Attachments
Subpart (e)
Installation, Maintenance, and Servicing Procedures
QT9 QMS Documents
Description
QT9 Module
Subpart (a)
Date of Manufacture
QT9 ERP Job
Subpart (b)
Quantity Manufactured
QT9 ERP Job
Subpart (c)
Quantity Released for Distribution
QT9 ERP Job / Inventory Transactions
Subpart (d)
Acceptance Records Demonstrating that the Device is Manufactured According to DMR
QT9 QMS Inspections/ QT9 QMS Documents/ QT9 ERP Job Routing Verification
Subpart (e)
Labeling
QT9 ERP Labels / QT9 ERP Job File Attachment
Subpart (f)
UDI or UPC, If Used
QT9 ERP Labels/ QT9 ERP Job File Attachment

Connect all the tools you use for electronic device history records

QT9 QMS enables you to integrate multiple business processes with electronic device history records. 

Benefits of eDHR software

Get started with features designed to help you take control of your device history records.

Centralize Your Data

Connect Device History Records data in one place and access it at any time.

Get Real-Time Analytics

Make informed decisions with real-time dashboards. Create your own customer views. 

Ensure Compliance

Show proof of proper handling, supporting FDA Current Good Manufacturing Practices (cGMPs). 

Link Records

Easily link eDHRs to related documents, audits, inspections and more.

Error-Proof Production

Identify and mitigate risks associated with production and compliance. 

Go Paperless

Store and easily access documentation, training, videos, pictures and more.

Improve Traceability

See a timeline of every action along with lot and serial traceability. 

Get More Done

Choose from over 40 pre-built modules to automate and improve efficiency. 

Transform how you manage device history records

Avoid the pitfalls of paper processes with QT9's electronic device history record solution. Data is seamlessly integrated from QT9 QMS and QT9 ERP with verification steps and lot approvals. Documentation, inspection plans and file attachments can be synced to your Bill of Materials (BOM) to create a complete eDHR or eDMR in once click. No paper needed. No separate folder structures.

See what quality leaders say about QT9 QMS

"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
"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
"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

FAQs: eDMR and eDHR software

What is a device master record (DMR)?

A device master record (DMR) is a file that includes all information and specifications needed to produce a particular medical device, including processes and materials used, drawings, labeling and packaging, and installation, maintenance and servicing procedures.

A DMR is required by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 820.

What is a device history record (DHR)?

A device history record is a lot-specific version of the device's DMR. An eDHR is a digital version of the traditional DHR.

Device history records are part of Good Manufacturing Practices (GMPs) and are required by international and national regulatory bodies, such as the U.S. Food and Drug Administration (FDA), to show that all requirements of the DMR have been fulfilled. Global regulators require manufacturers to maintain this information for each stage in the medical device’s life cycle.

 

What is a Bill of Materials (BOM)?

A Bill of Materials (BOM) is a comprehensive list of all materials and components needed to manufacture or repair a device, as well as directions for how to use them. 

single-level BOM is generally a simple list of assemblies and quantities needed.

A multi-level BOM is a hierarchical description of how each part is assembled. It lists every component of each part, including details such as quantity, part number and cost.

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