mimaTech provides comprehensive regulatory support for Medical Devices, throughout the product life cycle.

 

Our technical support focuses on the broad typology of products referred to in Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on Medical Devices for in vitro diagnostics, whose regulatory framework is complex. Due to it, many of the products already marketed are affected, and must be adapted to the new requirements, as well as new products, which must comply with the new regulatory requirements.

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We support our clients through strategic, technical, legal, documentary and management support, to ensure regulatory compliance, according to each market requirements.