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Medical Devices

Regulatory requirements are scrutinised in the manufacture, delivery, or service stages at each stage of your product's life.

Laboratories and other organisations in your industry are expected to demonstrate best practices by exemplifying a sound Quality Management System (QMS).

Are you keen to ensure the devices in your medical laboratory are safe, effective, and delivered to a high standard? Do you want to be updated on national and global requirements for your industry?

As a medical device manufacturer, the ISO 13485 standard is the most accepted global standard of its kind. If your business wants to focus on competency in its operations, IMSM can explain how this certification will improve and validate your work.

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; please download our free guide for further information.

ISO 13485 Digital Guide