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SARACA Solutions (SARACA) is a Global IT and 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 Medical Products/devices Market, Aerospace and Defense segments. We possess significant expertise in the areas of: Software Development, Clinical Evaluation Report, CER, EU MDR, IVDR, Technical Publications, Software Testing, Supplier Quality Engineering, Spine, Trauma, ENT, Ophthalmic, Remote Monitoring Systems, Radiology, Embedded electronics, Emergency Care and Single Use Devices. We have expertise in software development and testing with core focus on niche technologies including C++, C#, AngularJs, DOTNET and DevOps. We are experienced in various CAD packages (ex. ProE, SolidWorks) and international standards including GD&T per ASME Y14.5. We are highly proficient at working within regulated environments such as those imposed by the US FDA, EU MDR, IVDR and the EU (ISO13485, 21 CFR Part 820 QSR along with ISO14971 and IEC62304). Our skills include developing Design Dossiers (DHF/Tech Files), 510 (K) applications, UDI implementation, Remediation of the Class I, II and III products, and CAPA Management. Our best in class Team of engineers and designers possess extensive medical industry experience and have a keen understanding of the challenges faced by modern medical device companies. This understanding helps us in providing customized solutions to address the diverse needs of our customers. read more