TRIMEDX―an industry-leading, independent clinical asset management company delivering clinical engineering services, clinical asset informatics, and medical device cybersecurity―has been recertified with the highly regarded International Organization for Standardization’s Medical Device Quality Management System (MD QMS) certification ISO 13485, a widely recognized international standard outlining best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle.
This recertification, now valid through Aug. 2027, reverifies that TRIMEDX continues its dedication to maintaining a comprehensive quality management system (business policies and procedures), ultimately impacting its service excellence to clients.
“This reaffirms our commitment to excellence for our clients, associates, and stakeholders,” says TRIMEDX CEO Henry Hummel. “Our quality of service standardizes work and contributes to continuous improvement as we progress. By verifying these processes, we aim to achieve best-in-class customer satisfaction, quality service, and ultimately impact clients’ ability to ensure patient safety.”
This standard analyzes and evaluates everything TRIMEDX does from a risk perspective, so risk control is included in all parts of the business. ISO 13485 outlines best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle. TRIMEDX was recertified by third-party registrar DEKRA.
The ISO 13485 certification couples with TRIMEDX’s Service Organization Control (SOC) 2 Type 2 and ISO 27001 certification (valid through Dec. 2026) to make up TRIMEDX’s Quality Management System covering MD QMS and Information Security Management System (ISMS) standards.
“Achieving this level of compliance requires a continued commitment and demonstrated ability to monitor system activity and quickly take corrective action with the people, process, and technology in place,” says Denisa Lambert, vice president of quality & regulatory compliance. “Our comprehensive approach to data protection and responsive action sets us apart in delivering service excellence to clients.”