Design Verification - Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00
$149.00
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The ISO 13485 Design Verification and Validation Procedure defines governs design verification and validation activity being conducted as part of medical device development cycle.
  • ISO 13485 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 7-029

Design Verification and Validation Procedure

The Design Verification and Validation Procedure defines the design verification and validation activity conducted as part of medical device product development projects in accordance with FDA QSR and ISO 13485:2016. 

Design Verification and Validation Procedure - Overview

​The Design Verification and Validation Procedure addresses the design verification and validation elements of the design and development cycle.

Design Verification examines and provides objective evidence that the specified requirements of a product design have been fulfilled. 

​Whereas, Design Validation establishes by objective evidence that device specifications conform with user needs and intended uses(s).  

Design Verification and Validation Procedure - Compliance

​The Design Verification and Validation Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 compliant.
To learn more about our ISO 13485 Design Verification and Validation Procedure contact us at [email protected]

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iso 13485 design verification and validation procedure
Design Verification and Validation Procedure

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