Welcome to SARACA Solutions!


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.

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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.

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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.

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Global medical device industry is focused on innovationand improved technologies. The latest demand of devices isincreasingly bespoke rather than standard off-the-shelf. The demand is driven by surgeons and caregivers as an attempt toward better clinical outcomes to patients and reduced hospital stay. Implants are made in the wake of the realization that every patient has unique necessities. Read More


We possess expertise in Unique Device Identification (UDI) Implementation as per FDA mandate. We relentlessly supportour global customersto achieve target implementation date. Product Identification and Device Identification are two critical characteristics of the system and must be readable through labels directly marked on the devices, leaving out certain exceptions. Read More


In today's age of rapid information transmission through connected and smart devices, medical devices are connected to digital cloud as well for continuous monitoring and tracking. It helps in high-asset utilization by advance predictionof a failure and hence quick addressability of incidents. Using digital cloud also through mobile apps minimizes the downtime of machines. We have expertise in remote monitoring devices. Read More