RASC Ltd.

We are passionate about all AI-powered medical devices. Our holistic approach combines business acumen with a deep understanding of medical regulations. We work with Med-Tech companies developing cutting-edge technologies for digital health on the product concept definition and business strategy development and execution. We have a very strong background in Regulatory Affairs for active medical products and support companies in global market access by assuring products compliance with the worldwide regulations and local law applicable to active medical products, including technical requirements (medical safety, EMC, telecommunications, cybersecurity), and US national regulations Code of Federal Regulations Title 21, European Regulation (EU) 2017/745 (MDR), and other major markets regulations. We offer our expertise in product evaluation projects, certification, and registration including FDA. We also support companies in the development and implementation of the Quality Management System according to international requirements like ISO 9001 and ISO13485, and ISO/IEC 27001 Information Security System.