WHO WE ARE
SARACA is a global IT consulting and engineering R&D services company with Fortune 500 customers. 80% of our customers are based in the United States of America (USA) with a 95% recurring business. We provide services in medical technology, aerospace, defence, semiconductor, rail transportation, and automotive industries.
We offer services in the areas of software development and testing, mechanical design, embedded software and hardware development, technical publication, quality assurance, and regulatory affairs. We have expertise with a core focus on niche technologies including Python, C++, C#, AngularJS, ReactJS, Qt, QML, WPF, Big Data, .NET framework, and cloud.
Our service-oriented team possess extensive industry experience and has a keen understanding of the challenges faced by modern organizations. This understanding helps us provide you cost-effective and customized solutions.
We partner with our customers in the following industries.
MedTech & Healthcare
SARACA Solutions is a medical device engineering services company specializing in providing innovative and cost-effective contract resources and deliverables with a core focus on customer satisfaction. Our expertise extends to the areas of Orthopedics, Radiology, Pathology, Otology, Spine, Trauma, ENT, Remote Monitoring Systems, IoT Gateways, Embedded Electronics, Emergency Care and Single Use Devices.
Read MoreAerospace & Defence
SARACA Solutions is a global engineering services company which specializes in providing innovative and cost-effective deliverables with a core focus on customer satisfaction. Our business has a global reach and is focused on the Aerospace and Defence. We have expertise in mechanical, embedded systems, software development and testing with core focus on niche technologies.
Read MoreTransport & Automotive
SARACA has sound experience across rail transportation and its key segments, such as rolling stock, rail control, services, and infrastructure. Passenger experience is what makes train travel truly memorable and is the key differentiator in the transportation world.
Read MoreSemiconductors & Communication
The electronics industry expanded rapidly and the seeds for the semiconductor and software revolution were planted. SARACA provides consulting and engineering services that enable semiconductor companies to increase the productivity of their Characterization, Validation, Test, and Applications engineers through a suite of tools and platforms that enable rapid solution development and deployment. SARACA comprehensive semiconductor design services portfolio provides end-to-end development, testing, deployment, and life cycle support for silicon, platforms, boards, embedded software, product ecosystem, applications, and more.
Read MoreWe have full product development capabilities with a core focus on the following services.
Mechanical and Embedded Design
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
Read MoreQuality Assurance and Control
Medical device quality management systems are all about providing the rigor and discipline to drive product quality that meets customers' needs and delivers the information which is the life blood of management effectiveness.
Read MoreSoftware Development and Testing
We have expertise in software development and testing with a core focus on niche technologies including Python, C++, C#, Angular JS, React JS, Qt, QML, WPF, Big Data, Java, Micro services, .NET framework, DevOps and cloud services.
Read MoreTechPub and Documentation
SARACA provides services in technical publications related to the functional, operational, labelling, and maintenance aspects of a component, system, subsystem, or an assembly. We assist customers to convert legacy publications rapidly to the latest standards.
Read MoreRegulatory and Clinical Affairs
Medical device regulations are becoming increasingly difficult. We can help you comply with local, regional, and global regulatory requirements affecting your products. All major regulations have their own specific requirements, although there are harmonized essential requirements that are valid in each country.
Read MoreSourcing and Supply Chain
SARACA provides a structured approach to contract manufacturing by supporting our customers in their prototype and production manufacturing requirements. We have a comprehensive framework to identify, evaluate and select the best manufacturing partner for your unique product.
Read MoreSARACA has strong and extensive capabilities in emerging and trending medical device technologies. Our skills cover the essential needs for managing these products.
TECHNICAL FILE
SARACA writes Technical Files or STED for conversion of existing Tech Files to an EU MDR 2017/745 and EU IVDR 2017/746 compliant format. We provide consultative advice on the gap closure. We work with our customers to support decision making in line with their technical documentation strategy. Read MorePER
SARACA has expert writers in Performance Evaluation Report (PER) writing per Article 56 of the EU IVDR with focus on all three elements: scientific validity, analytical performance, and clinical performance. We have extensive experience in various segments including Pathology, Chemistry and Immunodiagnostics, Transfusion Medicine, and Cardiology. Read MoreCER
SARACA has broad expertise to work on your new CER or update as per MEDDEV 2.7/1 Rev 4 and EU MDR. We have completed more than 250 CERs in medical devices of class I, IIa, IIb and III classes. We have CER writers with extensive experience on MAUDE search and analysis; SOA, risk & benefit analysis and popular databases including PubMed, Embase, Google scholar. Read MoreINTERNET OF THINGS (IoT)
In today's age of rapid information transmission through connected and smart devices, medical devices are connected to the digital cloud as well for continuous monitoring and tracking. This helps in high-asset utilization by advance prediction of a failure and hence quick address ability of incidents. Read MoreWe work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
Case Studies
We have provided a few projects which we have executed for our customers. Please reach out to us for more details.