2304 MERCANTILE DRIVE
LELAND, NC 2845
CDB’s quality management system is certified and complies with ISO 13485:2016 standards to ensure consistent quality. At CDB we are proud to display showcase the BSI certification mark.
ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2016 provides a harmonized set of quality management system requirements for medical device manufacturers. ISO 13485 is currently recognized in most major markets (Europe, USA, Canada etc) and is a good base model for compliance with the EU CE marking Medical Devices Directives (Annex II, V, VI), Japan Pal requirements.
The CE mark is the official marking required by the European Community.
Quality starts at the top and should remain each step of the way. Our quality control is impeccably thorough because we know that your reputation is on the line. It begins with the design process, carefully listening to your specifications and reviewing them over and over to make sure no more improvements can be made. Then with each step of the manufacturing process we meticulously and continuously insure the maximum level of quality is achieved.
We do not simply adhere to quality control, we define it.
CDB Corp.’s certifications include ISO 13485, CE, FDA.
CDB’s quality management system adheres to the FDA’s quality system regulation 21 CFR Parts 808, 812, and 820, Medical Devices; Current Good Manufacturing Practice (cGMP).