Design Verification - Validation Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Design Verification and Validation Procedure governs design verification and validation activity being conducted as part of medical device development cycle.

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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 QMSR 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.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.