TRIMEDX awarded ISO 13485 certification

TRIMEDX, a technology-enabled provider of clinical engineering, medical device cybersecurity and clinical asset management solutions to healthcare systems, has been awarded the International Organisation for Standardisation’s Medical Device Quality Management System (MD QMS) certification ISO 13485:2016.

TRIMEDX has demonstrated its commitment to and achievement of world-class risk management, safety and quality in the delivery of our services to clients. This standard analyses and evaluates everything TRIMEDX does from a risk perspective, in perpetuity, so risk control is included in all parts of the business.

CEO Henry Hummel said: “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. 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. It reaffirms our commitment to continuously improve as an organisation for the clients we serve.

Denisa Lambert, vice president of quality and regulatory compliance, said: “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.”

This adds to TRIMEDX’s previously achieved certifications of ISO/IEC 27001:2016 and SOC 2 Type 2 covering data security. This provides evidence the company has implemented and certified a quality management system (business policies, processes and procedures). Together, these certifications combine MD QMS and Information Security Management System (ISMS) standards into the TRIMEDX Quality Management System.

Kristi McDermott, president of clinical engineering, added: “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. To our clients, achieving ISO 13485 certification demonstrates the commitment we have in ensuring our people, processes and technology are centred around keeping their patients safe.”