INDIANAPOLIS, 17th August 2021 / PRNewswire / – TRIMEDX, an industry-leading, technology-enabled provider of solutions for clinical technology, medical device cybersecurity, and clinical asset management for healthcare systems, announced today that it has been awarded the International Organization for Standardization’s highly regarded medical device quality management system ( MD QMS) Certification ISO 13485: 2016, a widely recognized international standard that outlines best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle.
TRIMEDX has demonstrated its commitment to world-class risk management, safety and quality in delivering our services to customers. This standard analyzes and evaluates everything that TRIMEDX does from a risk perspective over the long term, so that risk control is integrated into all areas of the company.
“In addition to verifying our core competence Clinical Engineering, TRIMEDX has gone one step further to thoroughly check and certify all of our business processes, including back office functions and business units, to ensure compliance,” says CEO Henry Hummel. “By reviewing these processes, we aim to achieve world-class customer satisfaction and quality service, and ultimately influence customers’ ability to ensure patient safety.”
The TRIMEDX business processes are certified as effective and conforming to the ISO 13485 standard for all business areas that support the company. This confirms that as a health technology company and health systems partner, TRIMEDX meets the latest standards for medical quality management systems while adhering to and enforcing policies and procedures to ensure regulatory credibility and customer trust. It confirms our commitment to continuously improve ourselves as a company for the customers we serve.
“This path to ISO certification shows our commitment to support patient care by improving product service and process quality in the healthcare technology industry through the implementation of our quality management system,” says Denisa Lambert, Vice President for Quality and Regulatory Compliance.
This complements the previously achieved certifications by TRIMEDX according to ISO / IEC 27001: 2016 and SOC 2 Type 2 for first-class data security. This provides evidence that the company has implemented and certified a quality management system (business guidelines, processes and procedures) that cannot be achieved by any internal or other external service provider. Together, these certifications combine the standards of the MD QMS and the information security management system (ISMS) to form the TRIMEDX quality management system.
“Our quality management system gives customers the reassurance that the core focus of TRIMEDX across the company is to ensure that one of their most important patient care assets – their medical devices – are consistently kept high quality, safe and compliant,” says Kristi McDermott, President for Clinical Technology. “For our customers, ISO 13485 certification demonstrates our commitment to ensuring that our people, processes and technologies are focused on patient safety.”
To learn more about TRIMEDX and its offerings, visit trimedx.com.
TRIMEDX is an industry leading independent clinical asset management company in The United States Provision of comprehensive clinical engineering services, clinical asset informatics and cybersecurity of medical devices. We help healthcare providers transform their clinical resources into strategic tools to lower operating costs, optimize capital expenditures on clinical assets, maximize patient care resources, and provide improved safety and protection.
TRIMEDX was developed by providers for providers and uses many years of experience in clinical engineering with data on 92% of all active medical device models.
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