Form preview

Get the free Device History Record

Get Form
This document describes the procedures for creating a Device History Record that contains complete production history of a finished product, and demonstrates product is manufactured in accordance
We are not affiliated with any brand or entity on this form
4,4
98,753 Reviews
4,5
11,210 Reviews
4,6
715 Reviews
4,6
789 Reviews

Get, Create, Make and Sign device history record

Edit
Edit your device history record form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share
Share your form instantly
Email, fax, or share your device history record form via URL. You can also download, print, or export forms to your preferred cloud storage service.

How to edit device history record online

9.5
Ease of Setup
pdfFiller User Ratings on G2
9.0
Ease of Use
pdfFiller User Ratings on G2
Here are the steps you need to follow to get started with our professional PDF editor:
1
Log in. Click Start Free Trial and create a profile if necessary.
2
Upload a document. Select Add New on your Dashboard and transfer a file into the system in one of the following ways: by uploading it from your device or importing from the cloud, web, or internal mail. Then, click Start editing.
3
Edit device history record. Rearrange and rotate pages, add and edit text, and use additional tools. To save changes and return to your Dashboard, click Done. The Documents tab allows you to merge, divide, lock, or unlock files.
4
Save your file. Choose it from the list of records. Then, shift the pointer to the right toolbar and select one of the several exporting methods: save it in multiple formats, download it as a PDF, email it, or save it to the cloud.
With pdfFiller, it's always easy to work with documents. Check it out!

Uncompromising security for your PDF editing and eSignature needs

Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
Learn more about security & compliance
GDPR
AICPA SOC 2
PCI
HIPAA
CCPA
FDA

How to fill out device history record

Illustration

How to fill out device history record

01
Gather all relevant device information, including serial number, model, and manufacturer.
02
Record the device's date of manufacture and acquisition.
03
Document all maintenance and calibration activities performed on the device.
04
Include records of any repairs or modifications made to the device.
05
Specify the dates and names of personnel involved in the maintenance and repair process.
06
Detail any incidents related to the device that may affect its safety or efficacy.
07
Ensure all entries are signed and dated by the responsible personnel.

Who needs device history record?

01
Healthcare providers who use medical devices.
02
Regulatory bodies auditing compliance with safety standards.
03
Quality assurance teams in healthcare institutions.
04
Manufacturers for tracking device performance.
05
Personnel involved in device maintenance and servicing.
Fill form : Try Risk Free
Users Most Likely To Recommend - Summer 2025
Grid Leader in Small-Business - Summer 2025
High Performer - Summer 2025
Regional Leader - Summer 2025
Easiest To Do Business With - Summer 2025
Best Meets Requirements- Summer 2025
Rate the form
4.6
Satisfied
23 Votes

For pdfFiller’s FAQs

Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.

When your device history record is finished, send it to recipients securely and gather eSignatures with pdfFiller. You may email, text, fax, mail, or notarize a PDF straight from your account. Create an account today to test it.
Install the pdfFiller Google Chrome Extension in your web browser to begin editing device history record and other documents right from a Google search page. When you examine your documents in Chrome, you may make changes to them. With pdfFiller, you can create fillable documents and update existing PDFs from any internet-connected device.
Yes, you can. With the pdfFiller mobile app for Android, you can edit, sign, and share device history record on your mobile device from any location; only an internet connection is needed. Get the app and start to streamline your document workflow from anywhere.
A Device History Record (DHR) is a comprehensive record that contains all the production and quality control information for a medical device, ensuring that the device was produced in accordance with the established specifications.
Manufacturers of medical devices are required to file a Device History Record to comply with regulatory standards and ensure traceability of their products.
To fill out a Device History Record, manufacturers must document the device's specifications, production processes, quality control tests, and any changes made during the manufacturing process, ensuring all entries are accurate and dated.
The purpose of a Device History Record is to provide evidence that a medical device has been manufactured according to the approved design specifications and is in compliance with the regulatory requirements.
The Device History Record must report information including but not limited to device specifications, manufacturing processes, inspection and testing results, dates of production, and any non-conformance issues that arose during production.
Fill out your device history record online with pdfFiller!

pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.

Get started now
Form preview

Device History Record is not the form you're looking for?Search for another form here.

Related Features

Delete Sentence in the Property Management Service Agreement with ease
Delete Sentence in the Email Cover Letter Template with ease
Delete Sentence in the Theatre Press Release with ease
Work In Photo in Excel with ease
Rub Out Photo in WRI with ease

Relevant keywords

Device History Record SOP Manufacturing Quality Control Quality Assurance Document Control Regulatory requirements Production Documentation Batch records Lot files

Related Forms

Form preview
VX9100 New cover 1
Vx9100 new cover 1.0.qed 3/18/08 2:24 pm page 1 by t e l f o
Fill Now
Form preview
F2250 User Guide
English f2250 user guide f2250 user guide part no. mmbb0181601 (1.0) h printed in korea
Fill Now
Form preview
GPRS Phone
English gprs phone users manual model: g5300 i please read this manual carefully before operating
Fill Now
Form preview
G7050 User Guide
G7050 user guide g7050 user guide english p/n : mmbb0093002 (1.1) some contents in this
Fill Now
Form preview
MODEL : G7100
Model : g7100 p/n : mmbb0098416 english issue 1.0 printed in korea users manual gprs
Fill Now
Form preview
GB106 EN WirelessFM MMBB0332301(1.2) .indd
Installing the sim card and charging the battery installing the sim card gb106 user guide
Fill Now
Form preview
rule of law in the western balkans - Aspen Institute
Become a member of therein her freud des aspen institute (association of friends of the
Fill Now
If you believe that this page should be taken down, please follow our DMCA take down process here .
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.