Stay Ahead of Compliance with Xcelrate UDI

Navigating the ever-evolving landscape of healthcare regulations can be challenging. Xcelrate UDI is here to help you remain compliant with the latest industry standards, ensuring patient safety and regulatory adherence at every step. We support your facility with solutions aligned to the solve ECRI warnings and the Joint Commission's R3 Report, which includes critical updates on infection prevention, and medical device management standards including the manufacturers requirement from the FDA to follow ISO13485 standards.

Effective February 2, 2026:

QMSR & ISO 13485

The new Quality Management System Regulation (QMSR) goes into effect on February 2, 2026. Hospitals must rapidly align their IFU processes with both the QMSR and the latest ISO 13485 requirements to mitigate audit risk. Is your hospital staff prepared to manage the new documentation and attestation requirements for medical device instructions for use (IFUs)? Manual compliance checks are time-consuming and prone to error.

Instantly download two FREE, Customizable Word Documents created to simplify hospital regulatory compliance.

Effective July 1, 2024:

Infection Prevention and Control: New and revised requirements for Critical Access Hospitals and General Hospitals.
Emergency Management: Updated standards for Ambulatory Care Programs and Office-Based Surgery Programs.

Our platform enables seamless compliance by validating manufacturer documentation, identifying recalls in real-time, and streamlining workflows that address these latest requirements. Xcelrate UDI ensures that your facility is equipped to meet these standards, helping you avoid compliance gaps that could impact patient safety.