Quality Connection (QC) Onsite Program

SafeLink's most comprehensive Quality Management program is designed to provide additional guidance to the lab through, not only complying with the FDA requirements, but also helping the lab infuse a "quality attitude" throughout the organization in every aspect of its business.

This package includes an intensive 2-day onsite visit by the assigned SafeLink consultant, a written customized Quality Manual, Standard Operating Procedures Manual, flow charts, plus a second, one-day follow-up visit. If you want more personalized attention, then this is the package for you.

Your Quality System will address the following:

• Determination of applicability and FDA registration (manufacture of Class II medical devices such as sleep apnea and snore guards requires registration; domestic labs outsourcing to offshore labs (and the offshore labs themselves) and labs that are re-packagers and re-labelers must register with FDA
• 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 control system

The completion of the QC program is accomplished through:

• Determination of your Management or Quality Representative and Quality Team - SafeLink works with representatives of management to set operating parameters and ensure that your core values are recognized in preparation of the quality assurance program.
• Onsite consultation with the QC Team to gather information and establish criteria for the QC Program.
• Establishment of timeline for completion of project.
• Completion of manuals: a) preparation of Quality Manual, b) incorporation of your current SOP's, if any, into a Standard Operating Procedures Manual that will meet quality assurance requirements, and c) direction for the preparation of SOP's in not already in place.
• Review of software being used to discuss viability of incorporating certain quality system components into electronic format, rather than implementation of manual controls.
• Roll-out meetings to all levels.
• Scheduled periodic assessments of the lab's progress.
• Access to consultant and technical phone/email support during project completion period.
• Assistance in preparation of your QS/GMP for third party certification under the Dental Appliance Manufacturers Audit Scheme (DAMAS), if requested.

Call SafeLink for a fee quote.

Are You Ready For The FDA?
Domestic or foreign manufacturers of dental appliances are required by the Food and Drug Administration (FDA) to have "a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States." Refer to www.fda.gov , Title 21, Part 820 for the regulation in its entirety. The federal regulation, Title 21, Part 820 requires: that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and, that complaints be processed.