Regulatory

Our field of activity moves forward  relentlessly with the development of new technologies, new standards and constantly higher customer expectations.
Our products and our services are constantly subjected to validations during the development, the manufacturing and followed during the clinical practice in order to always improve the satisfaction of our customers.
The CLARIANCE Quality System Regulation which have been initially set-up to comply with the ISO 13485:2003 and European Medical Device Directive 93/42/EC amended 2007/47/EC has also been built to comply with the 21 CFR 820 which is requested by US FDA.
CLARIANCE SAS and CLARIANCE, Inc. enforce compliance to these regulations with its employees and suppliers in order to improve the quality of our products and services to our customers.