Products by Saraca Solutions

We provide end-to-end Performance Evaluation Report (PER) services for in vitro diagnostic (IVD) medical devices to ensure compliance with EU IVDR 2017/746 and applicable global requirements. Our services cover the complete performance evaluation lifecycle, including development of the Performance...

We provide comprehensive Clinical Evaluation Report (CER) services aligned with major global regulatory requirements, including EU MDR 2017/745, UK Medical Devices Regulations 2002 (UKCA), US FDA clinical evidence requirements (21 CFR Parts 812, 814, and 820), Health Canada Medical Devices...

We provide comprehensive Software Quality Assurance (SQA) services to ensure medical device software meets the highest standards of quality, safety, and regulatory compliance throughout the product development lifecycle. Our SQA services are aligned with IEC 62304, ISO 13485, and applicable FDA...

We provide end-to-end regulatory compliance support for medical device and in-vitro diagnostic manufacturers under EU MDR (Regulation (EU) 2017/745) and EU IVDR (Regulation (EU) 2017/746), with a strong focus on complete, consistent, and Notified Body–ready technical documentation. We support...

SARACA Solutions delivers end-to-end Quality Management System (QMS) services for medical device and software-based medical device manufacturers, supporting compliance with ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR – 21 CFR Part 820). We support the development,...

We provide end-to-end global regulatory affairs support for medical device manufacturers across the United States and key international markets. Our services span the complete product lifecycle, including UDI implementation and remediation, design dossier and technical file preparation and updates,...

We provide comprehensive Post-Market Surveillance (PMS) services to help medical device manufacturers ensure continuous compliance, safety, and performance throughout the product lifecycle. Our PMS activities are aligned with EU MDR 2017/745, IVDR 2017/746, and other applicable global regulations,...

SARACA provides specialized Risk Management and Biocompatibility documentation consulting services for Medical Devices and In Vitro Diagnostics (IVDs) across the entire product lifecycle. Our services align with ISO 14971, ISO 24971, ISO 10993 series, EU MDR (2017/745), EU IVDR (2017/746), and US...

SARACA has in-depth capabilities in mechanical design, development and engineering in all the medical segments including implants, instruments and systems. Our mechanical designers and engineers have good expertise in innovative concept design, industrial design, detailing, geometric dimensioning...

Engineering Intelligence, Embedded in Every Device. Embedded engineering involves the development and testing of software that operates commercial and consumer devices, from an aircraft cockpit display to an MRI machine to the Bluetooth radio in a smartphone. Embedded engineering requires...

We specialize in delivering innovative electronics design solutions tailored to meet your medical device development needs. Our expertise includes analog and digital design, microcontroller and microprocessor-based systems, as well as IoT and sensor-based designs that ensure your devices are...

Let's make the world digital—drive business growth. We live in a digital era. New advancements in communications, data processing, and data storage technology are driving the next frontiers of progress. As global engineering services are refined by the continuing rise of emerging technologies and...

Designing the world for a better tomorrow. Mechanical Engineering is the cornerstone of industrial innovation, encompassing the design, development, and optimization of mechanical systems and processes. In today's dynamic landscape, Mechanical Engineering drives progress, efficiency, and...

Next-Gen Software Engineering Solutions: Transformative, Scalable, Secure. Your Partner for Custom Software Engineering Service. In the digital era, software has become the backbone of modern businesses, enabling automation, connectivity, and seamless user experiences. Software Engineering ensures...

Driving the Future of Mobility with Software-Defined Vehicles The Automotive industry is undergoing a massive transformation, with software playing an important role in vehicle operation. As vehicles evolve into software-defined entities, Saraca is at the forefront, helping OEMs, and Tier 1...

Fostering Innovation via Integrated System. Optimizing Performance & Efficiency. System engineering is a multidisciplinary approach to designing and managing complex systems over their entire lifecycle. It encompasses various engineering disciplines, such as mechanical, electrical, software, and...

Engineering Precision, Powering Progress. In today's digital world, Manufacturing Engineering plays a pivotal role in driving competitiveness and sustainability for businesses. By leveraging cutting-edge technologies such as automation, robotics, IoT, and data analytics, Manufacturing Engineering...

Optimizing SAP Performance with Expertise & Experience. SARACA’s AI-powered SAP Expertise. As a trusted partner of SAP, we at Saraca specializes in providing end-to-end SAP services that helps global enterprises to optimize their operations and drive scalable growth. From ERP implementation to...