Quality Policy

Orthodontic Design and Production, Inc. strives to deliver the highest quality orthodontic appliances on time, without defects, and competitively priced. This will be accomplished by training our staff to maintain and continually improve the effectiveness of our quality management system to ensure compliance with all applicable standards, regulatory requirements, and customer requirements.

Quality System Management

ODP's quality management system is certified to the ISO 9001:2000 and 13485:2003 standards to ensure consistent quality and high customer satisfaction. A quality management system is a common sense, well-documented system that ensures consistency and improvement of working practices, including the products and services produced. Quality management systems are based on standards, which specify a procedure for achieving effective quality management.

ISO standards contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner. They make trade between countries easier and fairer. They provide governments with a technical base for health, safety and environmental legislation. They aid in transferring technology to developing countries. ISO standards also serve to safeguard consumers, and users in general, of products and services.

ISO 13485:2003
Effective Quality Management Systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. Whatever devices they produce, medical device manufacturers have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device Quality Management Systems registration.

ISO 13485:2003 provides a good base model for compliance with the EU CE marking Medical Devices Directives (Annex II, V, VI), Japan Pal and Health Canada CMDCAS (class II, III & IV devices) requirements. ISO 13485:2003 is also considered to be fully compatible with the FDA QSR.

Click here to view ODP's ISO 9001:2000 certificate in PDF format. Adobe Acrobat PDF
Click here to view ODP's ISO 13485:2003 certificate in PDF format. Adobe Acrobat PDF

CE Mark for EU Member Countries

The CE mark is the official marking required by the European Community. CE Marking is often referred to as a 'passport' that allows manufacturers from anywhere in the world to sell their goods throughout the European market. In many countries within Europe, where a New Approach Directive is in force, CE Marking is a legal requirement for products, packaging and any accompanying literature. It proves to the buyer or user that the product fulfills all essential safety and environmental requirements as defined in the European Medical Device Directives.

Click here to view ODP's CE certificate in PDF format. Adobe Acrobat PDF
Click here to view ODP's declarations of conformity PDF format. Adobe Acrobat PDF

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

The FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. The FDA is a blending law and science aimed at protecting consumers. ODP's quality management system is compliant with the FDA's quality system regulation 21 CFR Parts 808, 812, and 820, Medical Devices; Current Good Manufacturing Practice (cGMP).

Click here to view ODP's FDA certificate to foreign government in PDF format. Adobe Acrobat PDF
Click here to view ODP's FDA registration status.
*Enter ODP's registration no. 2029191 and click on the search button.

GSA Contract Holder

As an approved supplier to the United States Government, ODP is proud to offer our complete line of products to Federal purchasers throughout the world. Through the U.S. General Services Administration's interactive website GSAAdvantage.gov, government buyers can order our products with full assurance that they are using the most reliable and proven source for thousands of Federal purchasers worldwide. GSA Advantage offers the most comprehensive selection of approved products and services from GSA/VA Schedules as well as all GSA Global Supply products.

Click here to view the GSA Advantage website

Material Safety Data Sheets

In 1988, the Department of Labor passed the Occupational Safety and Health Act (OSHA). In order to ensure chemical safety in the workplace, information must be available about the identities and hazards of the chemicals used in the workplace. OSHA's Hazard Communication Standard (HCS) requires the development and dissemination of such information through Material Safety Data Sheets.

Click here to view the ODP's Material Safety Data Sheets

For more information, please contact:

Mr. Richard Merrell
Regulatory Affairs Manager
Phone Extension 13
rm@odpinc.com