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.
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.
Manage your ISO 13485 compliance
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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.
Blog: CAPA for ISO 13485: medical devices
Effective CAPA management is a core pillar of ISO 13485, that is crucial for ensuring the health and success of your medical device company.
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ISO 13485 – the medical device standard explained
Fresenius Kabi
Leading healthcare company Fresenius Kabi Ltd have successfully worked with Ideagen’s Quality Management solution to reduce staff workload, improve the management of corrective and preventive actions (CAPA), and to get better control over their documents.
They removed their paper-based processes and implemented an electronic quality management solution to meet the requirements laid down by key regulatory bodies. Among a range of other certifications, they use Ideagen QMS to help maintain their ISO 13485 compliance, in what is a tricky regulatory environment on the European continent.
Ideagen Quality Management is built on a robust and stable base, which still forces processes to be followed. This means that system bypasses and shortcuts are not possible, improving the overall quality and safety in the long run – which is a major positive for the system.
More useful reading
ISO 13485 and its new role in the US
Harmonization between the Quality System Regulation and the ISO standard.
Read blogISO 13485:2016 7.3: Medical device design controls and why they’re important
Find out how can you apply, manage and use software to ensure you are compliant with the requirements.
Read blogISO 13485 software validation: everything you need to know
Follow our structured approach to demonstrate compliance to ISO 13485 before, during and long after you've implemented quality management software.
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