https://store-images.s-microsoft.com/image/apps.34134.9dbd8085-da6f-41ed-9c13-ab77beb45bb0.fbcca8e7-357b-4fbb-8c56-6ec98ceb92cb.4b7f0925-f5e5-455c-8b44-c6b7f2cd5645

CERTIFY

by Kobalt Software

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Helps Medical Device manufacturers integrate applicable standards and guides them in their process

Certify solution identifies the standards requirements applicable to your Medical Device and automatically creates the corresponding risks and technical requirements.
It respects the methodologies imposed by the ISO 14971 and IEC 62366 and creates standards reports in line with the expectations of testing laboratories and auditors.
Thanks to its real-time traceability management, from normative requirements to proves of compliance, you will have immediate impact analysis.
Certify solution is adapted to SaMD by helping manufacturers to follow IEC 62304 standard and reports.
Optimize, control and follow your certification process and maintenance !

Always available and up-to-date in Azure.

At a glance

https://store-images.s-microsoft.com/image/apps.63720.9dbd8085-da6f-41ed-9c13-ab77beb45bb0.fbcca8e7-357b-4fbb-8c56-6ec98ceb92cb.6af8d165-02b7-4381-a121-f92cf7f2c6b9
https://store-images.s-microsoft.com/image/apps.12577.9dbd8085-da6f-41ed-9c13-ab77beb45bb0.fbcca8e7-357b-4fbb-8c56-6ec98ceb92cb.fc868c80-4488-4506-9d9f-1f34e2c3f9d9
https://store-images.s-microsoft.com/image/apps.35628.9dbd8085-da6f-41ed-9c13-ab77beb45bb0.fbcca8e7-357b-4fbb-8c56-6ec98ceb92cb.34114235-18d7-4bb6-98dc-ea84c85d79b8
https://store-images.s-microsoft.com/image/apps.62039.9dbd8085-da6f-41ed-9c13-ab77beb45bb0.fbcca8e7-357b-4fbb-8c56-6ec98ceb92cb.e069c428-1930-4a7d-8e31-08e2176aba8a