What is DAMAS – Dental Appliance Manufacturers Audit System?The DAMAS (Dental Appliance Manufacturers Audit System) is an h 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 the dental laboratory to operate in compliance with product safety. It provides quality guidelines to help the dental lab improve documentation from dental prescriptions to material traceability. 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.
For a dental lab to obtain DAMAS certification, it must pass a third-party audit. Is your dental 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.
Benefits of Becoming a DAMAS Certified Dental Lab:The DAMAS specifications closely mirror the U.S. Food and Drug Administration’s Quality System/Good Manufacturing Practices (QS/GMP) regulations.
DAMAS helps the dental lab meet the FDA’s QS/GMPs and provide a dental laboratory-specific quality system. The DAMAS Specifications provide a clear-cut process for improving documentation in every facet of laboratory operation including: dental prescriptions/work authorizations; patient contact materials; subcontractor/supplier agreements; material and equipment purchases; employee training; maintenance and calibration of equipment; labeling; customer complaints; and material traceability.
Who should become DAMAS certified?DAMAS certification is for any dental lab interested in promoting the fact that the lab goes above and beyond governmental requirements by becoming certified to an internationally recognized quality management system specific to dental laboratories.
Learn more about the benefits of a Dental Lab Quality System & DAMAS Certification:
SafeLink today for more information on how we can help you obtain your DAMAS certification. SafeLink consultants can help you with:
- Determination of applicability for FDA registration
- 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