commitment to Quality
“By achieving both the requirements of the FDA’s 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. ”
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.