Credibility and Confidence in Your Dental Laboratory Work – How Quality Assurance Systems Can be Used in the Manufacturing of Individual Custom-Made Dental Devices

Abstract

Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. This paper provided a personal view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.

Keywords

Medicines and Healthcare products Regulatory Agency (MHRA)Medical Devices Directive (MDD)Duty of Candour CAD/CAM Manufacturing Dental Appliances GDC ISO 9001:2008 DAMAS Statement of Manufacture

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References

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