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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