"HELPING YOU REVOLUTIONIZE MEDICAL DEVICE TECHNOLOGIES"
SARACA Solutions is an innovative medical engineering services company, founded by a medical device outsourcing champion with a proven record of accomplishment in providing value to global medical device companies, with core focus on customer satisfaction.
Based in New Delhi, India, SARACA provides high quality and cost-effective engineering services numerous market segments including Orthopedic, Cardiology, ENT, Neuromodulation, Surgical, Imaging Systems, Remote Patient Monitoring, and Laboratory Equipment. We support our customers in Design, Quality, Manufacturing, and Regulatory Services for Single-Use Devices, Implants and Systems — Mechanical and Electrical.
In adherence to ISO 13485, FDA 21 CFR PART 820 QSR, and EU MDR, we collaborate with our customers starting from collecting marketing requirements, concept design, product development, supplier selection, prototype development and testing of the medical device products.
Our service-oriented team of engineers and designers possess extensive medical industry experience and has the keen understanding of the challenges faced by modern medical device companies. This understanding helps us in providing you cost-effective customized solutions.
SARACA has in-depth capabilities in medical device design and development of implants, instruments, software, systems, and new technologies in all the classes of medical devices. Our mechanical and electrical designers and engineers have good expertise in innovative concept design, DOE, 8D, Pugh Matrix, APQP, Risk Analysis, industrial design, validation, MSA, geometric dimensioning and tolerancing and sustenance engineering.Read More
SARACA provide a structured approach to contract manufacturing supporting our customers in their prototype and production manufacturing requirements. We work to take End-2-End ownership of manufacturing to assist our customers achieving their goals. Our capability ranges from the supply of a single component to the supply of Class I, II, III medical devices including systems, implants and instruments with clean room facilities.Read More
We have extensive experienced in FDA, EUMDR, CFDA, TGA, Health canada, and other major global regulations. We assist our customers in Design Dossiers, 510 (K), PMA, UDI, Remediation, CAPA Management, Gap Identification, Recommendation and Implementation for DHF/Tech Files for Orthopaedics, Spine, ENT, RPM, Trauma, Extremities, Radiology, Pathology, Cardiology, and many more segments. We will get your products to market quickly.Read More