CANI Optical Systems

As a leading Independent Service Organization(ISO) in the endoscopic equipment service industry, CANI has been recognized as a full service lab capable of repairing and maintaining all makes and models of flexible endoscopic equipment. While others claim to have this capability, we actually do it. And all repairs are performed in-house at Aberdeen,... Maryland Service Center. Our "Innovating Improvement(i2)" approach enables us to provide proven and repeatable improvements. By strategically managing the equipment's true life cycle, measurable benchmarks are identified and created from the first day of of CANI's proactive service programs. For more details on our Repair and Maintenance services, please call us at (888) 799-CANI(2264). By achieving both the requirements of the FDAs Quality System Regulation(QSR) and the voluntary Quality Management Systems(QMS) ISO13485 dedicated to the Medical Device industry, CANI Optical Systems continues to prove an unmatched commitment to quality for the service and products we provide. ” The quality systems for FDA regulated products are known as current good manufacturing practices (cGMP). As Class II regulated devices, the quality requirements for flexible endoscopes are detailed in the FDA's Code of Federal Regulations (CFR), Title 21 Part 820 which is also referred to as the FDA 21CFR820 . Unlike voluntary Quality Management Systems(QMS) like ISO9001 and ISO13485, the FDA's Quality System Regulation(QSR) is a requirement for all Medical Device Manufacturers. Our compliance to the requirements of the FDA 21CFR820 QSR provides clients the assurance that CANI products and services they receive are of the highest unmatched quality. ISO13485 : 2016 incorporates the latest revision to the original ISO13485 Quailty Management System standard for medical device regulations from around the world. Utilizing ISO9001 as the foundation, the ISO13485 : 2016 QMS was designed for companies serving the Medical Device industry. It differs from the general ISO9001 standard as additional ...Read More