# Compliance

Extra Horizon operates a Integrated Management system (IMS) in order to comply with the strictest security, privacy & quality requirements needed in order for our customers to thrive and run compliant, safe and secure Medical Device applications.

<figure><img src="/files/h93s9eYC7IeUs0dqwpfU" alt=""><figcaption></figcaption></figure>

### Platform Certifications

<table><thead><tr><th width="450.171875">Certificate</th><th></th></tr></thead><tbody><tr><td><strong>ISO 27001:2022</strong><br><strong>I</strong>s the <strong>international standard for Information Security Management Systems (ISMS)</strong>. It provides a <strong>systematic approach</strong> to managing sensitive company information so that it remains <strong>secure</strong>, covering people, processes, and technology.</td><td><img src="/files/AkqxCrv3MpxZhu4alMFW" alt="" data-size="original"></td></tr><tr><td><strong>ISO 27701:2019</strong><br>Is an international standard that provides guidance for implementing, maintaining, and continually improving a <strong>Privacy Information Management System (PIMS)</strong>. It extends the <strong>ISO/IEC 27001</strong> and <strong>ISO/IEC 27002</strong> standards, which are focused on information security management.</td><td><img src="/files/A0bBrtzlRwlwdIZba5Ya" alt="" data-size="original"></td></tr><tr><td><strong>ISO 13485:2016</strong><br><strong>I</strong>s an international standard that specifies requirements for a <strong>Quality Management System (QMS)</strong> specifically designed for the <strong>medical devices industry</strong>.</td><td><img src="/files/6KIPyMHzffriiwXGOsMk" alt="" data-size="original"></td></tr><tr><td><strong>HDS:2018</strong><br><strong>I</strong>s a French certification framework that sets <strong>security and compliance requirements</strong> for companies hosting health data.</td><td><img src="/files/uzfVZynsBDGQlRoARElX" alt="" data-size="original"></td></tr></tbody></table>

Extra Horizon is generally recognized as a key supplier within the Management Systems of our customers. As part of the supplier evaluation process, Extra Horizon provides up-to-date certificates to its customers as proof of compliance with relevant standards.

As a legal manufacturer of medical devices, you are required to validate the tools and platforms used to build your solutions. With the Extra Horizon platform, you can demonstrate compliance by leveraging Extra Horizon’s certificates and third-party audit reports, thereby minimizing the effort required to validate and demonstrate compliance on your own.


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