{"id":1722,"date":"2023-10-13T12:05:24","date_gmt":"2023-10-13T10:05:24","guid":{"rendered":"https:\/\/www.bayoomed.com\/zertifizierung\/"},"modified":"2026-10-02T15:44:25","modified_gmt":"2026-10-02T13:44:25","slug":"zertifizierung","status":"publish","type":"page","link":"https:\/\/www.bayoomed.com\/en\/zertifizierung\/","title":{"rendered":"Certification"},"content":{"rendered":"

Certifications<\/h1><\/h1><\/div>

BAYOOMED operates under a quality management system certified to ISO 13485.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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\"BAYOOMED\"BAYOOMED<\/div><\/div><\/div><\/div>

BAYOOMED Certifications<\/h1><\/h1><\/div>

BAYOOMED operates under a quality management system certified to ISO 13485.<\/p>\n<\/div><\/div><\/div>

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\"BAYOOMED<\/div><\/div><\/div><\/div>
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And T\u00dcV Hessen confirms this as well. Because u <\/span>Our quality management processes are certified to ISO 13485 and designed to be MDSAP-compliant.<\/span><\/p>\n

This quality policy commits us to developing secure, reliable, and equally innovative software solutions. At the same time, we never lose sight of the user experience. <\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>

\"BAYOOMED<\/span><\/div>

Download<\/a><\/p>\n<\/div><\/div><\/div>

Our Processes<\/h2><\/h2><\/div>

We use state-of-the-art technology while always keeping the latest and most current standards and guidelines in mind.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Software Engineering and Verification in Accordance with IEC 62304 \/ IEC 82304<\/h4><\/h4><\/div><\/div><\/div>
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Risk Management According to EN ISO 14971<\/h4><\/h4><\/div><\/div><\/div>
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Usability \/ Human Factors Engineering in accordance with IEC 62366 and \u201cApplying Human Factors and Usability Engineering to Medical Devices\u201d<\/h4><\/h4><\/div><\/div><\/div>
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Cybersecurity Risk Management in accordance with IEC 81001-5-1 and AAMI TR57 ( <\/span> for the FDA)<\/h4><\/h4><\/div><\/div><\/div>
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Validation According to GAMP 5<\/h4><\/h4><\/div><\/div><\/div>
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Information Security Management System in accordance with ISO\/IEC 27001<\/h4><\/h4><\/div><\/div><\/div><\/div><\/div>
\"Miriam<\/span><\/div><\/div><\/div>

Miriam Schulze
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Reaching Your Goal in Compliance with Regulations<\/h3><\/h3><\/div>

With our ISO 13485-certified quality management system and established processes that comply with the relevant standards, we not only create a reliable foundation for your medical software, but also guide you safely through the approval and market authorization processes.<\/p>\n

How can we support your project? Feel free to reach out to us\u2014together, we\u2019ll find the right path to your medical device or digital health application.<\/p>\n<\/div><\/div><\/div>

Contact Form<\/h3>\n

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