Dental Lab Services We offer a variety of consulting services to dental laboratories both large and small, all designed to suit every budget. Specifically, we have developed the International Dental Laboratory System (IDLS) that meets all the requirements mandated by the FDA under the 21 CFR Part 820 Regulations, that speaks to the industry's level of understanding and utilizes a common-sense approach.
The International Dental Laboratory System was designed by extensively experienced quality management system consultants, with world market experience. The IDLS was deemed necessary after our experiences since 2004, interfacing with and providing client solutions and responses to FDA auditors auditing laboratories in Texas for compliance to Federal Regulation 21 CFR Part 820.
The International Dental Laboratory System is private consulting and seminar based with availability for additional on-site consulting for seminar trained laboratories. Training and verification auditing and IDLS Certification are designed to ensure compliance with the FDA's QMS requirements.
Seminars - Small labs (Less than 20 employees)
The purpose of the seminar design is to defray the cost of Federal Regulation 21 CFR Part 820 compliance for smaller laboratories and ensure the same quality of consultation assistance afforded larger organizations. The benefits of the seminar program are straight-forward assistance with effective QMS implementation, the provision of the IDLS Handbook offering guidance and instruction on implementing these requirements, a software version FDA 21 CFR Part 820 compliant Procedure Manual that with minimal input provides the participant the primary compliance tool, as well as sample forms and evaluative tools specific to the dental laboratory business.
For schedules and dates contact our offices at (972) 671-9590.
On-site Consulting - Larger Labs
Larger organizations with greater than 20 to 25 employees are more complex, are generally tight on manpower, and have a greater need to benefit from the implementation of an effective quality management system. The benefit of using IMS for your QMS implementation is that you avail yourself of service performance benchmarks, i.e: calculable return on your investment (ROI); customized program development specifically structured around your operational functions; and development assistance in areas found needing effectiveness improvement using process-based tools. These are expected deliverables outside of the dental laboratory industry that are improving the results for our non dental-lab client organizations, and they are now available for your organization.
We believe by approaching FDA's mandate affecting the dental laboratory industry in a proactive cooperative manner, we can assist in the effort to sufficiently prepare the largest number of dental laboratories, large and small, in a way that will provide better comprehension through group interaction and/or personalized consulting. We have proven experience with providing developmental tools which, through the use of a strong efficient QMS, will benefit each organization significantly going forward.
