And this is also confirmed by T\u00dcV Hessen. This is because<\/span>our quality management processes are ISO 13485 certified and MDSAP-compliant.<\/span><\/p>\n This quality policy obliges us to develop secure, reliable and equally innovative software solutions. At the same time, we do not lose sight of the user experience.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div> We work with state-of-the-art technology and at the same time always keep an eye on the latest applicable standards and guidelines.<\/p>\n<\/div><\/div><\/div><\/div><\/div>![\"BAYOOMED](\"https:\/\/www.bayoomed.com\/wp-content\/uploads\/sites\/4\/2024\/09\/BAYOOMED-Unsere-13485-Zertifizierung.jpg\" "\\"BAYOOMED")
<\/span><\/div><\/div><\/div>Our processes<\/h2><\/h2><\/div>
Software development and verification according to IEC 62304 \/ IEC 82304<\/h4><\/h4><\/div><\/div><\/div>
Risk management according to EN ISO 14971<\/h4><\/h4><\/div><\/div><\/div>
Usability \/ Human Factors Engineering according to IEC 62366 and “Applying Human Factors and Usability Engineering to Medical Devices”<\/h4><\/h4><\/div><\/div><\/div>
Cybersecurity risk management in accordance with IEC 81001-5-1 and AAMI TR57 <\/span> (for FDA)<\/h4><\/h4><\/div><\/div><\/div>
Validation according to GAMP5<\/h4><\/h4><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1722","page","type-page","status-publish","hentry"],"yoast_head":"\n
Certifications<\/h2><\/div>What we are particularly proud of? On our sustainable business solutions and on the fact that we achieve the best results for you with our established processes.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div><\/div><\/div><\/div>![](\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\")
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What we are particularly proud of? On our sustainable business solutions and on the fact that we achieve the best results for you with our established processes.<\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>
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