Medidee is your partner for medical devices and IVD compliance in Europe and USA.

To fulfill regulatory requirements, the development of medical devices must result in a clinically validated device and a comprehensive Technical Documentation demonstrating the compliance.

Medidee acts as a one stop shop for the whole process including Clinical & Regulatory Consulting as well as the support for Quality Certifications and Supplier Controls.

The processes for design, industrialization, manufacturing, marketing and monitoring market feedback must be covered by a Quality Management System compatible with ISO 13485:2016 and/or USA QSR.

Medidee provides the necessary support to speed-up the process at all steps of the lifecycle of a medical device.

Routinely, innovators and investors rely on Medidee expertise in regulatory due diligence to make sure that reality meets expectations.

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