Common Sensing announces that the company has been granted ISO 13485:2016 certification. This certification is an international standard that outlines the requirements for a quality management system specific to the medical devices industry.
This certification validates the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. To be certified, Common Sensing demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“Quality is at the core of everything we do at Common Sensing, and this ISO certification represents an important milestone for our company. This reflects the focus we have on risk-based decision making throughout our organization with a commitment to safety and providing a high-quality product. We are very proud of our team and this accomplishment,” said Kevin Schmid, Chief Executive Officer of Common Sensing.
As part of the ISO certification process, Common Sensing participated in a thorough audit of its quality system processes, as well as product quality requirements. The company follows these standards throughout all departments such as design, manufacturing, assembly, distribution, and customer service. With this certification, health care providers and patients can be confident that Common Sensing is dedicated to maintaining the highest level of quality, efficiency, and responsiveness required by the medical community.
Download the certificate here.