Electronic Device History Record (eDHR) Software Made Easy
Join 16,000+ regulated manufacturers already using eDHR software — an industry growing at ~11% annually.
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
DHR compliance made easy for medical device manufacturers
Common Challenges With Device History Records (DHRs)
Paper, silos and compliance hurdles make DHRs harder than they should be. Here are four pain points manufacturers face — and how QT9 helps solve them.
Paper & Spreadsheets
Manual DHRs cause errors, delays, and missing data.
QT9 Fix: Go paperless with one-click eDHR/eDMR creation.
Traceability Gaps
Tracking lots, serials, and revisions takes too long.
QT9 Fix: Instant, audit-ready traceability across all records.
Regulatory Overload
FDA, ISO, EU MDR compliance is overwhelming.
QT9 Fix: Pre-validated tools automate signatures and revisions.
Disconnected Systems
Data silos create errors and slow audits.
QT9 Fix: Integrated QMS + ERP unifies quality and production data.
Benefits of Electronic Device History Record (eDHR) Software
With 62% of new deployments going cloud-based in 2024, you need a solution that supports scalable, connected operations.
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.
Streamline 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.
Pre-validated software platforms
QT9 solutions are 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 13585 |
• FDA 21 CFR Part 11 |
QT9 platforms include a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your platform to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
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.
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.
Modernize device history records
Employees waste 30% of their time searching for documents. With eDHR, everything’s traceable and at your fingertips.
- 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.
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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.
ERP compliance portal for regulated industries
Digitize device history records (DHR/MDR) and batch records (MBR/EBR) in one secure system. Trusted by medical device and pharmaceutical manufacturers across the U.S. and worldwide.
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Authorized auditors, inspectors, or compliance officers can securely log in to view or print compliance data — including MDR, DHR, MBR and EBR — without exposing unrelated ERP modules.
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This isolated audit view minimizes compliance risks, safeguards sensitive operational data and ensures faster inspections.
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Automatically compiles all required components — BOMs, routings, QMS documents, inspection data, job travelers and approvals — into one validated report.
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Eliminates manual data collection, reduces human error and saves manufacturers valuable time in preparing device and batch records.
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Seamlessly integrates with the QT9 QMS, ensuring MDR/DHR and MBR/EBR always reflect the latest approved documents, inspection plans, and production data.
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Guarantees only current revisions of controlled documents are included, maintaining full traceability and compliance.
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Automatically links production jobs, BOMs, materials, inspections, and approvals to each generated record.
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Helps manufacturers comply with FDA 21 CFR Part 210/211/820, ISO 13485 and GMP requirements.
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Provides a transparent, auditable trail from design through production, supporting both local and global regulatory demands.
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Supports single-level and multi-level record generation for complex assemblies or multi-stage production.
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Ensures visibility across all subassemblies, components, and processes, critical for regulated manufacturing operations.
FDA Part 820.181 device master record requirements
With the power of QT9 ERP and QT9 QMS, you can completely automate your device master records.
FDA Part 820.184 device history record requirements
With the power of QT9 ERP and QT9 QMS, you can completely automate your device history records.
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.
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.
1,000+ of the world's leading companies trust QT9
See what quality leaders say about QT9 QMS
FAQs: eDMR and eDHR software
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.
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.
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.
A 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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