Quality Management System (QMS)
Digitize your ISO 13485 compliance and boost your operational excellence with an agile, high-performance, tailor-made e-QMS.
THE e-QMS SOLUTION
An agile, reliable, and compliant system.
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ADN offers you high-performance, reliable, and affordable solutions for deploying an electronic quality management system that complies with the ISO 13485 standard. We support you in setting up this system, adapting it to your specific needs.
This e-QMS is compatible with all types of medical devices, whether active or non-active.
In addition, you benefit from an added advantage for medical device software through the use of IT tools, including the Atlassian suite, which is widely recognized and used by developers and engineers.
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Deployment compliant with ISO 13485
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Full compatibility with all types of MDs.
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Use of the Atlassian Suite (Jira, Jira Service Management, Confluence, Rovo).
Let's discuss your projects
OUR METHODOLOGY
Diagnostics to analyze, rigor to secure, and agility to perform.
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Our team assists you in developing and implementing your electronic quality management system within your company, in accordance with ISO 13485 standards.
We recommend an initial assessment through a diagnostic to identify your current status and guide you toward the relevant starting points. Next, we install and configure the Atlassian suite and its plugins. Finally, our experts validate this e-QMS to ensure its compliance and effectiveness.
We also provide specific training and ongoing support.
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Initial diagnosis and system assessment.
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Installation and technical configuration.
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Full regulatory validation.
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Financing assistance: Service eligible for 50% funding through the BPI's Medical Device Diagnosis program.
Let's discuss your projects