Medical Device Technologies
Improving lives through medical technology
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 Orthopaedics, Radiology, Pathology, Otology, Spine, Trauma, ENT, Remote Monitoring Systems, IoT Gateways, Embedded electronics, Emergency Care, and Single-Use Devices.
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.
We are highly proficient at working within regulated environments such as those imposed by the U.S. FDA, EU MDR, EU IVDR, ISO13485, 21 CFR Part 820 Quality Management systems along with ISO14971 and IEC62304. Our skills include software development and testing, Embedded Hardware and Firmware, mechanical Design, developing Design Dossiers (DHF/Tech Files), 510(k) applications, CER, PER, STED, UDI implementation, Remediation of Class I, II, and III products, and CAPA Management.
Expert in implementation of complex new regulations, including the EU MDR and IVDR and creation of CERs and PERs and strong clinical practice supporting EU requirements, providing strategies and turnkey approach to completion of CERs, PERs, and PMS-related deliverables (PSUR, SSCP, PMCF/PMPF plans and reports, PMCF/PMPF surveys).
We have extensive experience working on Orthopaedics, Spine, and Trauma segment. Our engineers have worked on the following sub-segments.
We have deep capabilities on concept design, development, verification and validation, quality, regulatory and post-market surveillance.
SARACA has worked in the design and development of Class I, IIa/IIb, and III medical devices:
Best-in-class project management by certified project managers who are seasoned device professionals focused on design, QA, and RA.
We have extensive experience in IVD devices in the pathology laboratory and over the counter devices:
We have experience in the design, development, quality, and regulatory of IVDR products in areas of cardiology, hematology, blood donor screening, infectious disease, gynecology, and women’s health.
We 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.”