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CERTIFICATIONS

O3 Enterprise considers compliance with the safety, quality and performance requirements of its devices essential in order to offer its customers solutions that comply with industry standards.

The company has been certified ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes” since 2010.

This guarantees a consolidated Quality Management System that complies with regulatory requirements during all phases of the product life cycle. In fact, the attention to quality is applied to the design, installation, maintenance and support services that O3 Enterprise provides to its customers.

Quality Policy

The ZEEROmed proposal includes devices that comply with the main industry standards, guaranteeing the safety, effectiveness and quality of the software:

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CE Marking
Compliance with European regulations: CE marking for diagnostic imaging visors according to the European Regulation MDR 2017/745.
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FDA K200546
Compliance with US regulations: FDA K200546 for the diagnostic image viewer – with the exclusion of mammography image and Digital Pathology slide viewing capabilities.
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Anvisa
Compliance with Brazilian regulations: ANVISA certification, register 81460810002 – only for medical devices that allow the storage and display of medical images.

The certified company management system guarantees the utmost attention during all phases of product life: from design to installation and maintenance, meeting all quality standards.

With years of experience and established expertise, O3 Enterprise constantly works to be in line with the latest regulations, offering safe and reliable software.

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