adapsia

Ensure that Class I medical devices remain in compliance with the requirements of Regulation (EU) 2017/745 (MDR), by ensuring regulatory compliance, the reliability of technical documentation, compliance with post-market surveillance and vigilance obligations, and the effective implementation of the quality management system both before and after the devices are placed on the market.

Ensure that Class Ir, IIa, and IIb medical devices, as well as all custom-made devices, remain in compliance with the requirements of Regulation (EU) 2017/745 (MDR), by ensuring regulatory compliance, the reliability of technical documentation, adherence to post-market surveillance and vigilance obligations, and the effective implementation of the quality management system both before and after their placement on the market.