Pulpdent Corporation has held Certification to ISO 13485 and the Medical Devices Directive 93/42/EEC since 1996. The Pulpdent Quality Management System has been assessed by its Notified Body, LNE/G-MED, and certified to the above standards and regulations as well as the requirements of the United States Code of Federal Regulations Title 21, Part 820, Quality System Regulation, and the Canadian Medical Devices Regulation for the design, manufacture and distribution of specialty products for the dental profession. While the ISO 9001 standard is a general model for a Quality Management System, ISO 13485 and the Medical Devices Directive are specific to the medical device industry and require stringent controls, such as formal risk management and an international vigilance system to protect both patients and health care personnel. Certification to the Medical Devices Directive allows Pulpdent to CE mark its dental products for sale in the European Community. Certification to the Canadian Medical Devices Regulations allows Pulpdent to hold Health Canada Licenses for the products sold in Canada.