SARACA Solutions, founded in 2014, is a leading international engineering services company providing solutions and services in quality, regulatory, mechanical engineering, and open source software development for the medical device industry. The company is based in New Delhi, India, with a location in Fair Play, SC. Our technical and service capabilities range from complete end to end solutions to special requirements for medical OEMs and service providers. SARACA mechanical and embedded engineers have strong technical backgrounds in Design, Engineering, and global regulatory standards – US FDA, EU MDR, EU IVDR, MDD, ISO 13485, TGA, 21 CFR Part820, ISO 62304 and ISO 14971.