WE WORK FOR

    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.

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Aerospace & 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.

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Transport & 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.

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Semiconductors & 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.

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WHAT WE OFFER

We 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

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Quality 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.

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Software 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.

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TechPub 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.

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Regulatory 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.

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Sourcing 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.

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TRENDING TECHNOLOGIES

SARACA 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 More

PER

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 More

CER

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 More

INTERNET 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 More

CLIENT TESTIMONIALS

We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.

Case Studies

We have provided a few projects which we have executed for our customers. Please reach out to us for more details.

White Papers

Our medical device experts are at the forefront of the changes in the medical device industry and happy to share a few of the published white papers.

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