In these critical times, the 1MED Team stands alongside manufacturers, assisting in the development and implementation of the optimal regulatory strategy for each product.
We provide comprehensive support in drafting all necessary clinical, technical, and quality documentation in a thorough and compliant manner.
At 1MED, our top-tier, multidisciplinary regulatory and quality team brings a wealth of experience across multiple therapeutic areas. We are equipped to offer valuable assistance in navigating and overcoming the complexities of the new regulatory framework. With the 1MED Compliance Pack™ – a distinctive, straightforward, rapid and cost-effective tool – we offer tailored support to manufacturers.
This ensures smooth and successful MDR application submissions to NBs, mitigating the risk of missing the critical 26 May 2024 deadline.