Optim LLC, a premier manufacturer of proprietary flexible endoscopes for use in the visual diagnosis of Ear-Nose-and-Throat (“ENT”) disorders, as well as components for the Ultrasound industry, announced today the company has upgraded to the new ISO 13485:2016 standard for Medical Devices and Quality Management Systems (QMS) from Intertek Testing Services. This internationally recognized standard sets out the prerequisites for a quality management system specific to the medical device industry.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements
“Optim’s commitment to quality products and processes remains a cornerstone of the company”, stated Doug Hughes, President and CEO of Optim. “with the implementation of ISO 13485:2016, Optim is in complete compliance with the latest Medical Device regulatory requirements, with is critical as we continue to develop and market innovative visualization products.” In addition, Optim can apply these same quality systems to the other non-medical devices we manufacture for industrial and security markets.
The ENTity Series of flexible laryngoscopes are utilized daily to diagnose and manage airway, voice, and swallowing disorders. The ENTity Series features the company’s proprietary self-contained LED illumination system, providing practitioners with a high-quality, easy-to-use imaging device that can be employed in nearly any health care setting without ancillary equipment common to other endoscopy systems. In addition, Optim manufacturers other medical and non-medical devices under the same quality system and standards.
Information about Optim’s products is available at www.optim-llc.com | 508.347.5100.