Customer Care: Quality
At Cylex, we believe in quality and we
care about all of our customers, both domestic and international.
Cylex is committed to delivering high quality products, responsive customer care,
innovations and improvements that exceed customer expectations in all areas
of our business.
We strive to continually improve our Quality System utlizing
global customer feedback and empowering employees to maximize
resources and increase shareholder value.
We operate our business in a safe and respectful environment,
fully compliant with all applicable regulatory requirements.
Cylex is proud to be certified to ISO 13485:2003
and ISO 9001:2008.
Certification to ISO standards is a baseline quality
system requirement in key markets for approval to sell a medical
device. This designation supports plans to market the ImmuKnow immune
cell function assay to customers around the world. Certifications
confirm implementation of quality systems in product development,
operations, shipping and service. They support CE marking of Cylex
products labeled for in vitro diagnostic use for sale within
the European community. Additionally, Cylex meets global quality
design and manufacturing requirements for Canada.
ISO (International Organization for Standardization) 13485:2003
+ AC:2007; ISO
13485:2003; and ISO
9001:2008 assure Cylex customers in the United States, Europe
and Canada that quality systems are in place and meet strict, internationally
recognized standards for design, development and manufacturing
of medical products.
The ISO 13485:2003 certification
includes compliance with the Canadian Medical Devices Conformity
Assessment System (CMDCAS). Health
Canada is the federal regulator of therapeutic products, including
medical devices – it reviews medical devices to assess their safety,
effectiveness and quality before being authorized for sale in Canada.
The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate,
Health Canada is the Canadian federal regulator responsible for licensing
medical devices like ImmuKnow in
accordance with the Food and Drugs Act and Regulations and
the Medical Devices Regulations.