IVD Factory

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IVD Factory

IVD Factory is an operational approach using Design Control to streamline the product development process towards compliance with US and EU regulatory requirements.

By integrating of regulatory requirements into the product development process, extra time and cost for subsequent studies etc. to meet regulatory requirements are eliminated.

The IVD Factory concept is designed for small diagnostic companies to commercialize IVD products faster and cheaper.

Please contact us for an informal presentation of the IVD Factory concept and discussions on how it may help your company.