Welcome to SARACA Solutions!


SARACA Solutions is an innovative medical engineering services company, founded by a medical engineering outsourcing champion with over 15 years of proven record of accomplishment in providing value to global medical device companies, with its core focus on customer satisfaction. We provide services in Orthopaedics, Spine, Trauma, Radiology, Pathology, Laboratory Equipment, Emergency Care and Single Use Devices, and Remote Monitoring Systems. We support our customers in Design, Quality, and Regulatory Services.

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 superior team of engineers and designers possess extensive medical industry experience and has keen understanding of challenges faced by modern medical device companies. This understanding helps us in providing customized solutions.



We are proficient in designingimplants, instruments, and systems of all classes of medical devices perUS FDA, EUMDR and other high regulatory agencies. Our team of designers has co-invented implants, associated instruments, and systems that have been successful in the market. Starting from CAD/CAE (Solidworks, Creo, Ansys) capabilities to working prototypes, we can do all. Our engineers have expertise on GD&T.

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We source the best possible talent for a job to ensure successful outcome. Our large network of engineers in various fields - Mechanical, Electrical, Quality, Regulatory, Design, Embedded, etc.- with vast experience ensures acquisition of the right candidate and on time. We strive to source unique talent, suitable to client's requirements at various global locations. We provide extensive training to our network engineers

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We are experiencedin USFDA, EUMDR, MDD, CFDA, TGA, Health canada CE, and other major global regulations. We are skilled in Design Dossiers, 510 (K), PMA, UDI, Remediation of the Class II and III products, CAPA Management, Gap Identification, Recommendation and Implementation for DHF/Tech Files for Orthopaedics, Spine, Trauma, Extremities, Radiology, Pathology, Cardiology, and many more segments.

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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