Innovating the Approach to Equipment Management

As an emerging medical device manufacturer and an established independent service organization (ISO), CANI Optical Systems, Inc. specializes in all areas of flexible endoscopy and focuses on creating innovative products and services which have measurable improvements and advantages over our competitors' devices and repair services. 

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).

commitment to Quality

fda       21cfr820 

 FDA's Quality System Regulation (QSR)

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

Quality Management Systems (QMS) for Medical Devices

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 focus is applied to specific areas. This includes, but is not limited to, areas such as cleanliness of products, contamination controls, and risk management.

Our commitment to being an ISO13485 : 2016 certified Medical Device organization ensures our customers requirements are met and the effectiveness of our Quality Management System is maintained.