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ISO
9001:2000,
ISO 13485:1996,
Medical
Devices Directive 93/42/EEC
Pulpdent
Corporation continues to hold Certification to ISO 9001:2000,
ISO 13485:1996 and the Medical Devices Directive 93/42/EEC.
Bureau
Veritas Quality International (N.A.) Inc. has assessed the
Quality Management System of Pulpdent Corporation and finds
it to be in accordance with the requirements of ISO 9001:2000
for the design, manufacture and distribution of specialty
products for the dental profession.
G-MED,
Paris, has assessed the Pulpdent Quality Management System,
developed specifically for the design, manufacturing and sales
of medical devices for professional dental use, and certifies
that it complies with the requirements of ISO 13485:1996 and
EC Medical Devices Directive 93/42/EEC. Certification to the
EC Directive allows Pulpdent to place the CE Mark on its dental
products and to sell them in the European Community.
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.
Pulpdent
Corporation has been manufacturing products for the dental
profession since 1947. Its products are sold through more
than 1000 dental dealers in over 75 countries.
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