TRIMEDX obtains ISO 13485 – Med-Tech Innovation certification

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TRIMEDX, a licensed provider of clinical engineering technology, medical device cybersecurity and clinical resource management solutions for healthcare systems, has achieved ISO 13485: 2016 certification from the International Organization for Standardization of the Quality Management System of medical devices (MD QMS).

TRIMEDX has demonstrated its commitment and achievement of a world-class level of risk management, safety and quality in providing our services to clients. 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.

CEO Henry Hummel said: In addition to verifying our core clinical engineering expertise, TRIMEDX has gone a step further to thoroughly review 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 the best customer satisfaction, quality service, and ultimately impact customers’ ability to ensure patient safety.

TRIMEDX business processes have been certified as effective and compliant with the ISO 13485 standard for all business units supporting the company. This confirms that TRIMEDX, as a health technology company and health systems partner, meets the latest medical quality management system standards by maintaining and enforcing policies and procedures to ensure regulatory credibility and customer trust. It reaffirms our commitment to continually improve as an organization for the customers we serve.

Denisa Lambert, Vice President of Quality and Regulatory Compliance, said: This ISO certification path demonstrates our commitment to supporting patient care by improving product service and process quality in the health technology industry through the execution of our quality management system.

This is in addition to the certifications previously obtained by TRIMEDX of ISO / IEC 27001: 2016 and SOC 2 Type 2 for data security. This provides evidence that the company has implemented and certified a quality management system (company policies, processes and procedures). Together, these certifications combine the 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 customers confidence that TRIMEDX’s primary goal across the company is to ensure that one of their most critical assets for providing patient care is their medical devices are consistently maintained in a high quality, safe and compliant manner. For our customers, achieving ISO 13485 certification demonstrates our commitment to ensuring that our people, processes and technology are focused on protecting their patients.

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