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prSRPS CEN ISO/TS 23485:2026

Medical Devices -- Quality management systems -- Guideline for the application of ISO 13485:2016

General information

10.99     Apr 18, 2025

ISS

Z076

Technical Specification

English  

Scope

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.

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prSRPS CEN ISO/TS 23485:2026
10.99 New project approved
Apr 18, 2025

Related project

Adopted from prCEN ISO/TS 23485 IDENTICAL

Adopted from ISO/CD TS 23485 IDENTICAL