prCEN ISO/TS 23485

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

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.