NADL Heightens Industry Awareness

If one were to ask almost any laboratory owner what one of their biggest challenges is, the answer would likely revolve around finding, and keeping, good employees.  Even laboratories that are open to hiring those new to the industry and training are still struggling to just find people. This employment gap, however, is not unique…

FDA Inspections Are Not All the Same – Two Recent Cases

In the past decade, the FDA has increased the number of device manufacturing establishment inspections. Pre-COVID, in 2017, the FDA conducted 2,952 inspections of medical device firms, representing a 46 percent increase compared to a decade earlier. FDA also increased foreign inspections 243 percent. In 2018, FDA regional field offices launched inspections of dental laboratories…

Update March 2023: How to find the Right Dentist for your Patient Needs

In most of our lifetimes, we will all need the services of a dentist. This blog is intended to help you determine the right dentist for your needs. First, a basic overview on dental degrees.  The DDS (Doctor of Dental Surgery) and DMD (Doctor of Dental Medicine) are both dental degrees. They are awarded upon…

Collaboration Equals Better Case Acceptance

Collaboration between dental laboratories and dental offices plays a significant role in the future of the dental industry. Advancement in digital tools has increased collaborative abilities via sophisticated dental technology and virtual communication innovations. There is no guarantee that patients will accept a treatment plan. Patients’ reluctance to accept treatment is primarily due to their…

FDA QSR UPDATE – ISO 13485 Alligned QMSR Final Rule Getting Closer

By Eric Thorn, Esq Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published…

Standards Matter – Why it is Important to Work With a CDT, CDL or DAMAS Laboratory

STANDARDS MATTER Why it is Important to Work with a CDT, CDL or DAMAS Laboratory By: Heather Voss, CDT Whenever we drive a car, purchase something online, use a cellphone or take our children to an amusement park, we are benefiting from minimum quality standards without even knowing it.  Standards have become such an integral…