Medical Device

Validated Cloud compliance adheres to 21 CFR Part 11, HIPAA, ISO 13485:2003 and Annex 11, and its Quality system is built in accordance to 21 CFR Part 820. The advances in technologies and connectivity of remote sensors allow medical devices to follow patients and clients using their mobile phones as a relay to send data from the device to the cloud. Validated Cloud will help you deploy those cloud systems on a compliant platform. Our cloud is completely customizable for the needs of data-aggregation services. Validated Cloud also handles traditional compliance systems for the complete solution.

Why Are We The Best?

Validated Cloud will host your document management system of your choice. We also have Qualification documents to give a compliant SharePoint environment a great head start.
Validated Cloud will host the Quality Management System that meets your business requirements.
Validated Cloud offers a library of IQ/OQ Qualification documents for common Operating Systems and Databases ready to host your application.
Validated Cloud


The path to customers of new products typically starts in the EU. Our European datacenter gives you all of the same benefits of Validated Cloud on European soil. Budget in dollars or euros. Validated Cloud’s networks span both continents and gives you the power of an international GxP private cloud for all of your validated system hosting needs.


Separate Compliance Networks

Have two networks in your private cloud – one to adhere to FDA open system rules and another for closed systems. Each network can be secured independently. The systems exposed to the internet then can have a secure channel to the internal system for analytics.


Avoid system-based 483s

The FDA predicate rule necessitating a Qualified infrastructure still applies. Using Amazon, Azure, Rackspace or other generic cloud providers can leave you exposed. These cloud providers cannot be made compliant.

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Validated Cloud is the best choice for Medical Device Compliance systems

Contact us to learn more. The process is easier than you might think and not much more than generic cloud hosting.
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