Medical Devices - Quality management systems - Guideline for the application of ISO 13485:2016
Abstract
This document provides guidance on the intent of the requirements in ISO 13485:2016, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. The document does not prescribe mandatory approaches to implementation or provide any preferred method of interpretation.
Begin
2025-04-18
WI
JT003077
Planned document number
prCEN ISO/TS 23485
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible european committee
CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
