ISO 13485:2016

Medical Devices Quality Management Systems

 

ISO 13485 specifies requirements for a Quality Management System for companies required to demonstrate their ability to provide medical devices that consistently meet client and regulatory requirements.

In this introductory guide, you will learn:
 

  • What is ISO 13485?
  • Who needs ISO 13485?
  • What are the benefits of ISO 13485 to your business?


IMSM can provide consultancy services to assist you in implementing ISO 13485; for further information, please download our free guide.




 

 

 

 

 

Download Your Guide

 

How can IMSM help my business gain ISO 13485?

Our role is to support and guide your business towards certification. Our experienced assessors will help your business audit and improve its quality management systems, offering training and support where necessary. We take out all the heavy lifting and our experts will help you each step of the way.


The standard is designed to be comprehensive, focusing on quality and smoothly integrates with other Management Systems.

The IMSM Approach

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