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).

Orthopaedics, Spine, and Trauma:

We have extensive experience working on Orthopaedics, Spine, and Trauma segment. Our engineers have worked on the following sub-segments.

  • Joint replacements – Knee, Hips, Ankle implants and instruments
  • Spine – Thoracic, Lumbar, Cervical, Pedicle Screw Systems, Interbody Devices, 3D printed implants
  • Trauma – Plates, Screws, MIS instruments
  • Navigation systems – Surgical Robots, Surgery Navigation Software Systems

We have deep capabilities on concept design, development, verification and validation, quality, regulatory and post-market surveillance.

Cardiovascular and Radiology:

SARACA has worked in the design and development of Class I, IIa/IIb, and III medical devices:

  • Cardiac Rhythm Management (CRM) - pacemaker and defibrillators
  • Patient Monitors Systems
  • Heart Valves, and Stents
  • Perfusion Packs and Urology 
  • Heart lungs machine and Oxygenator
  • X-ray, MRI, and Ultrasound Systems
  • Hospital Beds, Physiotherapy Systems
  • Ophthalmic and ENT Products

Best-in-class project management by certified project managers who are seasoned device professionals focused on design, QA, and RA.

In-vitro Diagnostics:

We have extensive experience in IVD devices in the pathology laboratory and over the counter devices:

  • Transfusion Medicine
  • Immunodiagnostic System
  • Chemistry System
  • Remote Patient Monitoring
  • Laboratory Automation & IT
  • Point of Care Diagnostics
  • Molecular Diagnostics
  • Clinical Chemistry

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.

CLIENT TESTIMONIALS

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

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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