Ever wonder if Asian dental laboratories are complying with quality system regulations the same as U.S. dental laboratories? The importance of compliance should be foremost in all dental laboratories whether they are U.S. domestic or foreign.
During my recent visit to China I was able to audit two facilities and both had done superior jobs in documenting their Quality System. The visits purpose was to analyze and identify gaps in their compliance systems. This is a service that we can provide to any lab. If you are working with Asian labs, then we can audit to ensure that you are protected by ensuring that they are meeting medical device compliance. SafeLink Consulting can assist in preparing for MDSAP audit (Medical Device Single Audit Program) and perform a Gap Analysis to assure that the Asian lab can do business in USA, Canada, Brazil, Australia and Japan.
SafeLink Consulting can also assist with DAMAS for Asia. The DAMAS (Dental Appliance Manufacturers Audit System) is an international standard based on FDA regulations for the manufacturing of dental devices. U.S. 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 the dental lab improve documentation from dental prescriptions to material traceability.
Contact SafeLink Consulting if you see a benefit to your company by being DAMAS certified or ISO registered. We are one of the premier FDA consulting firms in the dental industry assisting labs with medical device US import requirements. Our FDA compliance consultants are knowledgeable of the dental environment.
3 Ways Your Product Offerings Can Trigger FDA's Attention:
Are you a manufacturer of dental devices? Need Quality System consulting or other dental compliance services?
Here's what SafeLink Consulting can do for you:
- Quality Management consulting
- Quality Management training online courses
- Quality System Regulation Risk Assessment
- FDA consultants
- 510k consultants
- DIY Quality Systems Lab
- Quality System Manual