Create a DHR template for your manufacturing process
Enter your product details, choose the sections you need and define your manufacturing operations. The generator creates a preview you can print to PDF or export to CSV.
DHR template preview
Review the generated document before printing or exporting it.
How to use a Device History Record template
Identify the device and production record
Use identifiers that allow the record to be associated with the correct device, lot, batch or production order. Include the relevant product specification, manufacturing procedure and revision references. Determine whether individual serial numbers, batch records or both are needed.
Document manufacturing and material traceability
Include the operations and material relationships necessary to demonstrate that the required manufacturing activities were completed. Depending on the device, this can include component lots, supplier information, equipment, operators, process parameters, inspections and special processes.
Record inspections, tests and exceptions
Reference approved procedures and acceptance criteria. Capture actual results where required, identify the person or system recording them, and document failed results, nonconformances, rework and dispositions through controlled processes.
Review completeness before release
Establish a defined review process for missing entries, unresolved exceptions, inspection results, labeling and packaging checks, and required approvals. Define who can authorize release and how the decision is recorded.
Control the approved template
Give the approved template a document number and revision. Establish change control, access permissions, record retention and retrieval requirements. If the template becomes part of an electronic record system, evaluate the controls applicable to that system and its intended use.
Frequently asked questions
What is a Device History Record (DHR)?
A Device History Record documents the production history of a particular medical device or applicable production batch, including evidence that required manufacturing and quality activities were completed.
What should a DHR template contain?
A template may include product and lot identification, applicable specifications and revisions, materials and components, manufacturing operations, inspection and test results, deviations, traceability, review and release approvals. The appropriate content depends on the device and manufacturing process.
Is this template automatically FDA compliant?
No. This generator creates a customizable starting document. Manufacturers must determine applicable requirements, verify the required content, establish controlled procedures and ensure that records provide the necessary evidence.
What is the difference between DHR, DMR and DHF?
A DHR records the manufacturing history of a device or applicable batch. A Device Master Record (DMR) describes the specifications and instructions used to manufacture the device. A Design History File (DHF) contains documentation of the design and development history where applicable.
Can I use the generated template electronically?
You can use the downloaded template as a starting point for a controlled electronic record process. Your organization must separately assess access controls, record integrity, electronic signatures, audit trails, retention and any applicable validation requirements.
Can I customize manufacturing steps?
Yes. Add, remove or edit manufacturing steps, inspections and tests before generating the template. Review the resulting fields against your approved manufacturing instructions and quality procedures.