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AgPlus Diagnostics

Quality

Quality assured practices and products are central to the success of our business.

Customers can be assured that every stage of our technology development is compliant with ISO13485 and 21 CFR 820 standards for medical devices. This ensures that our development partners are able to seamlessly integrate any technology developed on their behalf into their required regulatory compliance systems. For example, for CE IVDD and/or FDA approval.

Please contact us if you require further information about our quality standards.