Leading the Way for Third-Party Companies That Manage, Service Medical Devices
Crothall Healthcare today announced its Crothall Facilities Management Inc’s – Healthcare Technology Solutions (HTS) operating division has received ISO 13485-2016 certification from NSF International Registrar based out of Ann Arbor, Michigan. Crothall’s registration scope is as a full life cycle medical device service provider, offering equipment management, technical support and OEM equivalent repair services of clinical and diagnostic equipment nationwide, making Crothall one of the only Independent Service Providers in its class that manages and services medical devices to receive this certification.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of standards for quality management systems. The ISO 13485 standard sets requirements for a quality management system designed to ensure medical device safety, risk management and process improvement. It recognizes that Crothall’s policies, practices and procedures ensures consistent quality in the repair and support services provided to its clients.
Crothall’s HTS division manages and provides oversight of a hospital’s entire life cycle of medical devices and clinical technologies. It is one of the largest US companies managing and servicing medical devices, serving more than 175 hospitals nationwide.
“The ISO 13485 certification ensures our clients that we meet the highest level of quality management systems recognized in the healthcare industry,” said Jim Cheek, president of Crothall Healthcare Technology Solutions. “It is the platinum standard for quality management and, building upon ISO 9001, the ISO 13485 Standard recognizes our risk reduction processes aimed at making the safety of our clients, their patients and medical devices our top priority.”
“I am extremely proud of the work our team put into the development and implementation of our comprehensive plan to achieve ISO 13485 certification” Cheek said. “We believe the certification demonstrates our commitment to quality and patient safety, and will help differentiate us from our competitors.”
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