Capabilities Statement

Founded in 2019 by Melendez, leveraging 37 years in healthcare, IT, and medical device sectors, Xcelrate UDI leads in UDI adoption, IFU access, and real-time recall notification at the point-of-use. Specializing in accurate device identification and instant manufacturer IFU access, our ONC CEHRT-certified solutions comply with Joint Commission standards, and FDA regulations and integrate seamlessly with EHRs and ERPs. This integration not only enhances patient safety but also optimizes EDI transactions, improving medical device identification. Our platform provides immediate recall notifications, actively preventing potential device-related risks. Adhering to ISO13485, we're committed to reducing risks and enhancing patient care.

Xcelrate UDI Statement of Compliance with Quality Assurance and ISO 13485 Standards

At Xcelrate UDI, we are deeply committed to upholding the highest standards of quality and excellence across all facets of our operations. Our dedication is mirrored in the stringent internal quality management systems (QMS) we've established, aimed at ensuring our products and services consistently fulfill customer needs, adhere to all regulatory demands, and foster ongoing enhancement.

Compliance with ANSI/ASQ Z1.4: Our adherence to the ANSI/ASQ Z1.4 standards is demonstrated through our employment of detailed sampling plans and inspection procedures, guaranteeing our products' quality aligns with both our high standards and customer expectations. This approach is rooted in systematic sampling and quality control measures for batch acceptance or rejection.

Alignment with ISO 9000 Series & ISO 13485: Though not officially certified, Xcelrate UDI has meticulously developed and executed a QMS that embodies the principles and best practices of the ISO 9000 series, with particular emphasis on ISO 13485, which is specific to medical devices. This system is geared towards enhancing customer satisfaction, improving processes, and ensuring regulatory compliance, reflecting the essence of ISO 9001 and the specialized requirements of ISO 13485.

Adherence to ISO 10012-1: Our measurement management system complies with ISO 10012-1 standards, ensuring all operational measurements and tests are accurate, reliable, and consistent, thereby bolstering the quality of our offerings.

Commitment to MIL-Q-9858 and MIL-STD-45662A Principles: By integrating essential aspects of the MIL-Q-9858 and MIL-STD-45662A standards into our quality assurance strategies, Xcelrate UDI embraces robust military-grade quality system requirements and calibration processes, enhancing our products' reliability and performance.

Continuous Improvement and Real-Time Efficiency: We are dedicated to perpetual improvement, regularly revisiting and refining our quality management approaches to align with industry benchmarks and evolving best practices. Our solutions verify against the FDA's GUDID in real-time, facilitate streamlined EDI transactions, and provide immediate recall notifications, thereby advancing healthcare technology and patient safety.

Seamless Integration and Safety Innovations: Our ONC CEHRT-certified solutions integrate flawlessly with existing healthcare systems, reinforcing safety and regulatory conformity. Xcelrate UDI prioritizes technological advancements and patient care, focusing on mitigating device-related hazards through prompt recall alerts.

While not formally certified, Xcelrate UDI's practices and QMS are designed to resonate with the spirit and directives of these esteemed standards. We are unwavering in our commitment to quality, continually monitoring our alignment with these and related standards to exceed our customers' and stakeholders' expectations.

For further information about our quality assurance practices or our dedication to excellence, please reach out to our Quality Management Team.