Contract manufacturing for the orthodontic and dental industry

Quality Policy

CDB is dedicated to quality and continuous process improvements for both customers and employees.  Our responsibility is to ensure that through established standards and measurements, the level of quality at CDB meets our customers’ expectations.  

Quality is an integral part of our commitment to world-class products and customer service.  The management of CDB ensures compliance to governmental, safety and environmental regulations.

Quality System Management

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices.  ISO 13485 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.

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.

Food and Drug Administration (FDA) Certificate to Foreign Government (CFG)

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).

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CDB Corporation

2304 Mercantile Drive
Leland, NC 28451
Phone: 910.383.6464
Fax: 888.280.1556