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DAMAS Consulting and Certification

Dental Appliance Manufacturers Audit System

The DAMAS (Dental Appliance Manufacturers Audit System) is an international standard based on FDA regulations for the manufacturing of dental devices.

Domestic or foreign manufacturers of dental appliances are required by the Food and Drug Administration (FDA) to have a quality system for the designing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices intended for commercial distribution in the United States.

DAMAS certification provides a system that assists labs to operate in compliance with product safety. It provides quality guidelines to help labs improve documentation from dental prescriptions to material traceability. In order for your lab to obtain DAMAS certification, it must pass a third-party audit. DAMAS improves efficiency and productivity, integrates good management disciplines, improves customer service needs and customer confidence, provides a competitive edge, reduces waste of materials and manpower, reduces risk and liability, improves ability to increase profitability, provides a formal process to help meet FDA QS/GMP requirements.

Is your lab ready for a third-party audit? SafeLink provides DAMAS consulting services to help you structure your quality system to comply with DAMAS specifications. SafeLink Consulting is also an approved DAMAS Certification Auditor. SafeLink will help you with the following:

  • Determination of applicability for FDA registration (delete everything after this in parantheses)
  • Assignment of management responsibility
  • Defining of purchasing controls
  • Identification/traceability of patient contact materials
  • Production and process controls
  • Acceptance of final product
  • Review of Non-conforming product
  • Corrective and Preventive Action procedures
  • Control of Labeling and Packaging
  • Handling, Storage, Distribution and Installation of materials and finished items
  • Records retention and document control

Contact SafeLink today for more information on how we can help you obtain your DAMAS certification.

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  • Address: 327 Dahlonega Street, Suite 601A
    Cumming, GA 30040 USA
  • Phone: (770) 205-6745
  • Email: support@safelinkconsulting.com
  • Monday - Friday: 9:00 am - 5:00 pm
    Saturday - Sunday: Closed
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