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

The IMSM approach is based on a key set of principles in order to create balanced and sustained results for our clients.
Read More

Is ISO Worth It?

As a leading ISO consultancy, we're passionate about ISO but know you may be wondering, "Is ISO really worth it."
Read More

Be Our Next Success Story!

Since 1994 we have assisted many clients in achieving their ISO dreams. Join them and be one of our many success stories.
Read More
“We are very satisfied with the service we have received from IMSM over the years. From initial certification to upgrading to new revisions of the ISO standard, IMSM has been with us at every step.”

- Keith M.