ISO 13485 knowledge hub
Useful resources and information to help you unlock compliance with ISO 13485, the definitive standard for quality in medical device organizations across the globe.
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Ideagen Quality Management has allowed us to look at ways and areas where we can continually improve, developing the business. It allows us to keep our customers satisfied with our services while maintaining the levels of quality they have come to expect.
Erik Paulsen, Quality Coordinator, Fresenius Kabi
What is ISO 13485 and why is it important?
ISO 13485 is an international standard specifying requirements for quality and competence in medical device organizations. Organizations involved in the production of medical devices are most commonly accredited, but the standard also applies to organizations involved in the design, installation, servicing, and in some cases the distribution, of medical devices and related services.
A medical device encompasses any product – whether that be an instrument, machine, implant or in vitro reagent – intended for use in the diagnosis, prevention, and/or treatment of diseases and other medical conditions.
If your organization plays any role in the production and use of these devices, you would likely benefit from ISO 13485 accreditation.
ISO 13485 downloads
Explore our range of ISO 13485 resources that are designed to help you meet and maintain the standard.
ISO 13485 compliance checklist
Meeting the requirements of ISO 13485 can be daunting, so we have put together a checklist for you to use to track your medical device organization’s readiness to meet its demands.
Ideagen QMS for ISO 13485
In this guide learn how Ideagen Quality Management can help medical device organizations meet the specific requirements of ISO 13485 by listing the clauses and sub clauses of the standard and identifying the integrated modules of Ideagen QMS that are appropriate to each.
Understanding ISO 13485
This guide provides an overview of key sections of the standard, explaining what they mean in practice. You'll also find a downloadable compliance checklist covering specific clauses and checks needed to ensure ISO 13485 compliance in your medical device setting.