In the medical device and medical technology sector, innovation matters as much as the ability to carry that innovation into international markets. CE Marking, which opens the door to the European market, FDA Approval, mandatory for the United States, and compliance with the regulations of other local markets are complex processes that demand specialized expertise.
At Şah Grup, we act as the strategic partner of medical device manufacturers through these demanding processes, ensuring your products reach global markets quickly, safely and completely.
We offer an end-to-end service model covering every step you need to access global markets:
We manage the CE Marking process — mandatory for selling medical devices in the European Union market — within the framework of the current Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR).
We guide you through the FDA (U.S. Food and Drug Administration) approval processes required to enter the world's largest medical market, the United States.
In line with our global vision, we help you achieve compliance with local regulations for other target markets as well.
We don't just prepare paperwork — together we define the most efficient market entry strategy for your product and your company.
Thanks to our multilingual team and global network, we have a firm command of the regulations of different countries.
We manage the entire process on your behalf, from initial analysis to final approval, saving you time and resources.
We closely track constantly evolving medical device regulations to keep you a step ahead at all times.
Take the first step to bring your innovation to the world today. Get in touch with us to meet our expert team and build a roadmap for your products.
