ISO 13485 Recertification Awarded to TRIMEDX

TRIMEDX has gained ISO 13485 recertification. The widely recognized international standard outlines best practices for developing an effective medical device Quality Management System (QMS) that covers the safety and quality of devices throughout their lifecycle.
 
Valid through Aug. 2027, the recertification verifies that TRIMEDX maintains a comprehensive QMS (business policies and procedures), ultimately impacting its service to clients. 
 
“This reaffirms our commitment to excellence for our clients, associates, and stakeholders,” TRIMEDX CEO Henry Hummel said. “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.

---

READ MORE: TRIMEDX Introduces Real-Time Location System for Medtech Inventory

---

The ISO 13485 certification couples with TRIMEDX’s Service Organization Control (SOC) 2 Type 2 and ISO 27001 certification (valid through December 2026) to comprise TRIMEDX’s QMS covering medical device and Information Security Management System 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,” stated Denisa Lambert, TRIMEDX’s vice president of quality and regulatory compliance. “Our approach to data protection and responsive action sets us apart in delivering services to clients.”
 
TRIMEDX is an independent U.S. clinical asset management company that delivers clinical engineering services, clinical asset informatics, and medical device cybersecurity. The firm helps healthcare providers transform their clinical assets into strategic tools, driving reductions in operational expenses, optimizing clinical asset capital spend, maximizing resources for patient care, and delivering improved safety and protection. TRIMEDX was built by providers, for providers, and leverages a history of expert clinical engineering with data on 92% of all active medical device models.