ISO 13485-1:2016

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

 By downloading this guide, you'll learn:
  • What is ISO 13485-1:2016?
  • What are the key benefits to your business?
  • What is involved in getting certified?

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What is ISO 13485?

ISO 13485 is the most accepted global standard of its kind and will bring your business a host of benefits, including:
IMSM strive to make ISO certification as simple as possible for our clients.


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Cut Out Waste

ISO 13485 will help to optimise efficiency and minimise costs.


Ensure Quality

ISO 13845 builds a quality system that meets the demands of legislation in every corner of the global market.


Build Better Processes

ISO 13485 will establish robust development, manufacture, distribution and control processes.