# Device History Record (DHR) Template for Medical Device Batches

> Source: https://netray.co/tools/device-history-record-template
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

Build a device history record for one lot or serial number: quantities, dates, labeling, acceptance and release sign-off. Exports to PDF or Word.

## Category

quality

## Industry

Medical Devices

## Audience

- Quality engineer
- Production supervisor
- Regulatory affairs

## Tool

**Kind:** template

**Output:** document

**Fields:**

#### Manufacturer

**Key:** company

**Type:** text

**Default:** Meridian Orthopedics Inc.

#### Device name and model

**Key:** device

**Type:** text

**Default:** Cannulated bone screw 4.0 mm x 36 mm, model CS-4036

#### Lot or serial number

**Key:** lot

**Type:** text

**Default:** L2610-0417

#### Work order / production order

**Key:** work_order

**Type:** text

**Default:** WO-118204

#### Device master record / device file reference

**Key:** dmr

**Type:** text

**Default:** DMR-CS-4036 Rev F

#### Quantity manufactured

**Key:** qty_made

**Type:** number

**Default:** 500

#### Quantity released for distribution

**Key:** qty_rel

**Type:** number

**Default:** 492

#### Production start date

**Key:** start

**Type:** date

**Default:** 2026-10-05

#### Production end date

**Key:** end

**Type:** date

**Default:** 2026-10-12

#### Labeling and UDI used

**Key:** label

**Type:** text

**Default:** Label LBL-CS-4036 Rev C, UDI-DI (01)00812345000417, lot (10) and expiry (17) printed

#### Acceptance activities summary

**Key:** accept

**Type:** textarea

**Default:** Incoming material cert verified (Ti-6Al-4V ELI, heat 7731). In-process dimensional checks per sampling plan. Final inspection per INS-CS-4036. Passivation and cleaning validated process PV-014.

#### Nonconformances during this lot

**Key:** nc

**Type:** textarea

**Default:** NCR-2291: 8 pieces scrapped for thread gauge fail. No other deviations.

**Blocks:**

#### Device History Record

**Body:** Manufacturer: {{company}}
Device: {{device}}
Lot / serial: {{lot}}
Work order: {{work_order}}
Device master record: {{dmr}}

#### Quantities and dates

**Body:** Quantity manufactured: {{qty_made}}
Quantity released for distribution: {{qty_rel}}
Production start: {{start}}
Production end: {{end}}

#### Manufacturing steps

**Table:**

**Columns:**

- Step
- Operation / instruction ref
- Date
- Operator
- Result

**Rows:**

**0:** 10

**1:** Material receipt and verification

**0:** 20

**1:** Machining / forming

**0:** 30

**1:** Cleaning and passivation

**0:** 40

**1:** Final inspection

**0:** 50

**1:** Packaging and sterilization

#### Acceptance records

**Body:** {{accept}}

#### Labeling and identification

**Body:** {{label}}

#### Nonconformances and deviations

**Body:** {{nc}}

#### Release

**Signatures:**

- Production supervisor
- Quality assurance reviewer
- Authorized releaser

**Notes:** This is a starting point built from the typical content of a device history record, not legal advice. Your device master record, procedures and the regulation that applies to you (21 CFR Part 820 as amended, EU MDR, or other) define what your DHR must contain. Keep the completed record with the lot and retain it for the period your procedure requires.

## Content

**Intro:** A device history record proves that a specific lot or serial number was built and released according to its device master record. This template gives you a clean structure you can fill in and export, then attach to the lot paperwork.

**Sections:**

#### How to use this template

**Body:** Enter the manufacturer, device, lot or serial number, work order and the device master record revision, then add quantities, dates, labeling, acceptance results and any nonconformances. Export to PDF or Word and complete the step table and signatures by hand or in your document system. One record covers one lot or serial number, so make a new one for every production order.

**Bullets:**

- Always reference the revision of the device master record used
- Record quantity made and quantity released separately
- Cite NCR and deviation numbers instead of describing them again
- Keep the label and UDI printed on the lot with the record

#### What the record has to show

**Body:** Under the old FDA Quality System Regulation the DHR was defined in 21 CFR 820.184: dates of manufacture, quantity manufactured, quantity released, acceptance records, the primary identification label and any device identification and control numbers. ISO 13485 clause 7.5.1 asks for a record for each medical device or batch that provides traceability and identifies the amount manufactured and approved for distribution. Check which version of the rule applies to your market, because FDA moved to the Quality Management System Regulation that incorporates ISO 13485.

#### Worked example

**Body:** A orthopedic screw lot of 500 pieces is built under work order WO-118204. Eight pieces fail a thread gauge check and are scrapped under an NCR, so 492 pieces are released. The DHR shows 500 made, 492 released, the NCR reference, the passivation process validation, the label revision and the three signatures. An auditor can pick the lot number and trace every claim back to a source record in minutes.

#### Common mistakes

**Body:** The usual failures are a blank release signature, a quantity released that does not match the shipment, a missing reference to the DMR revision, and records that say pass without the measured value. Paper DHRs also grow slowly because people attach loose inspection sheets; list every attachment by document number so nothing gets orphaned. In an ERP, the work order, lot and inspection results often already exist and can feed the record automatically.

**Cta:** If your lot, inspection and nonconformance data already sit in SAP, Infor, Epicor or NetSuite, Netray can help assemble the DHR from that data on your own infrastructure, with a human approving release.

**Faq:**

#### What is a device history record?

**Answer:** It is the record of how one batch, lot or unit of a medical device was manufactured and accepted. It shows dates, quantities, what was released, acceptance results and labeling, and proves the device was built to its device master record.

#### Is a DHR the same as a batch record?

**Answer:** In practice the terms overlap. Batch record is common in pharma and general manufacturing. DHR is the medical device term, and it carries device-specific content such as UDI, labeling and release for distribution.

#### How long must a DHR be retained?

**Answer:** Retention is set by regulation and your procedure. A common rule is the expected life of the device but not less than two years from release, and EU MDR sets its own periods. Confirm with your regulatory affairs lead for each market.

#### Can a DHR be electronic?

**Answer:** Yes. Electronic records are accepted if the system is validated, access controlled and audit trailed. For FDA this means meeting 21 CFR Part 11 expectations where they apply. Many manufacturers build the DHR from MES and ERP data.

## Search terms

device history record template, DHR template, device history record example, medical device batch record template, 21 CFR 820 device history record, ISO 13485 production record, DHR checklist, electronic device history record

---
Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json