TRIMEDX, Indianapolis, announces that it has been awarded the International Organization for Standardization’s Medical Device Quality Management System (MD QMS) certification ISO 13485:2016, 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 standard analyzes and evaluates everything TRIMEDX does from a risk perspective, in perpetuity, so risk control is included in all parts of the business.
“In addition to verifying our core competency of clinical engineering, TRIMEDX has taken a step further to thoroughly examine and certify all of our business processes, including back-office functions and business units, to ensure compliance,” says CEO Henry Hummel. “By verifying these processes, we aim to achieve best-in-class customer satisfaction, quality service, and ultimately impact clients’ ability to ensure patient safety.”
The TRIMEDX business processes have been certified as effective and compliant according to the ISO 13485 standard for all business units supporting the company. This confirms TRIMEDX, as a healthcare technology company and health system partner, meets the latest medical quality management system standards while maintaining and enforcing policies and procedures to ensure regulatory credibility and client confidence.
“This ISO certification journey demonstrates our commitment to support patient care by improving product service and process quality within the healthcare technology industry through the execution of our Quality Management System,” says Denisa Lambert, vice president of quality and regulatory compliance.
This adds to TRIMEDX’s previously achieved certifications of ISO/IEC 27001:2016 and SOC 2 Type 2 covering data security. Taken together, the company’s certifications combine MD QMS and Information Security Management System standards into the TRIMEDX Quality Management System.
“Our Quality Management System gives confidence to clients that TRIMEDX’s core focus across the company is ensuring one of their most critical assets to deliver patient care―their medical devices―are consistently maintained in a high-quality, safe and compliant manner,” says Kristi McDermott, president of clinical engineering. “To our clients, achieving ISO 13485 certification demonstrates the commitment we have in ensuring our people, processes and technology are centered around keeping their patients safe.”
