Device History Record Procedure

$149.00
$149.00
Unavailable
per item
The Device History Record Procedure governs the creation of a Device History Record (DHR) of a finished device or critical component for each work order and establishes the process for final release into finished goods.
 
  • ​ISO 13485:2016 Compliant
  • ​FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format
  • ​Digital Content - Instant Download ​
SKU: SOP 7-019

Device History Record Procedure

The Device History Record (DHR) Procedure governs the creation of a Device History Record (DHR) of a finished device or critical component for each work order and establishes the process for final release into finished goods.

Device History Record Procedure - Overview

The Device History Record (DHR) Procedure governs the process of compiling and completing documentation made part of the DHR.

Completion of the Device History Record, and associated DHR checklists, becomes documented evidence that the device batch / lot has been manufactured in accordance with the Device Master Record (DMR).

Device History Record Procedure - Compliance

The Device History Record (DHR) Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 compliant.
Device History Record Procedure
Device History Record Procedure

Customer's also viewed

Medical Device Quality Management System | BASE PLUS SYSTEM

$1,799.00

The Medical Device Quality Management System | BASE PLUS is configured for companies engaged in the design and manufacture of medical devices who need only the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 38 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view

Medical Device Quality Management System | DESIGN PLUS

$2,699.00

The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 46 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download 
view

Medical Device Quality Management System | MANUFACTURING

$2,899.00

The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 60 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view

Medical Device Quality Management System | MANUFACTURING PLUS

$3,599.00

The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view
Copyright © 2010-2024
  •