Author

Gary Morgan, CDT, CQA/ASQ

Gary Morgan, CDT, CQA/ASQ, Senior Vice President & Partner of SafeLink, has over 30 years of hands-on experience in dental, medical device manufacturing, and general industry compliance. As Partner, he helps dental practices and laboratory owners build safer workplaces and stronger quality management systems. A frequent presenter at national events, Gary has served on state and national advisory boards including NADL's representative to the ADA Standards Committee, earning the NADL Merit Award and the DLAT Hall of Fame Award. Gary is an Authorized Trainer under OSHA’s Outreach Program, a Certified Quality Auditor, and a Certified Dental Technician.

September 3, 2026

QSR vs. QMSR: What Changed & What It Means for Device Manufacturers

QSR vs. QMSR: What Changed and What It Means for Manufacturers For three decades, FDA investigators evaluated device manufacturers against a single, homegrown rulebook: 21 CFR Part

Dental lab techician working with dental impression teeth models

August 25, 2026

More Than a Manufacturer: Dental Labs and Patient Privacy

Dental laboratories have long operated at the intersection of clinical care and skilled manufacturing. What has been less clear for labs, for the practices they serve, and for regu

FDA establishment registration on laptop

August 20, 2026

FDA Establishment Registration: A Guide for Dental Laboratories

If you mill certain implant abutments in-house, manufacture sleep apnea or anti-snoring devices, or import finished devices from overseas, there's a good chance FDA's establishment

March 24, 2026

Ortho Labs Be Aware - FDA is Watching!

Take note ortho labs - FDA is watching what you are marketing. Recently some labs, specifically orthodontic labs, have received letters from FDA inquiring about the marketing of ce

August 5, 2025

Benefits of a Document Control System in a QMS

The paperwork generated by a Quality Management System (QMS) can be overwhelming unless you implement a structure that is simple and user-friendly. The data can be retained in auto

Analyze customer feedback voice of customer

April 22, 2025

Listening to the Voice of the Customer (VOC)

In today’s competitive business environment, having effective methods in place to capture the Voice of the Customer (VOC) is essential. Listening to your customers enables your bus

January 30, 2025

How Would Your Management Controls Stand Up in an FDA Inspection?

One part, and usually the initial part, of an FDA inspection covers management controls. If you have a Quality Management System developed, then the documentation should be in plac

December 16, 2024

FDA Registration Renewal: 7 Steps for FY 2027

October 1 marks the start of the FDA's annual registration renewal period. Every medical device establishment that has to register must renew between October 1 and December 31 (21

December 11, 2023

Measuring Suitability and Effectiveness of your Quality System

As this year comes to a close and organizations move forward with their business planning for the new year, it’s important to remember that the Quality Management System (QMS) requ

April 19, 2023

6 Types of QMS Audits & Why Your Business Should Perform Them

What is a Quality Management System (QMS) Internal Audit and why is it so important? Understanding the purpose and accepting the value of a Quality Audit is vital for the effective

April 18, 2023

Why SOPs Are the Backbone of Healthcare Compliance

If your organization is regulated by the FDA, subject to HIPAA, or covered by OSHA workplace safety standards, Standard Operating Procedures (SOPs) aren't just good business practi

January 30, 2019

4 Steps to Good Work Instructions in your Document Control System

Successful businesses have established standards to meet their customer’s needs and wants. It doesn’t matter if the business is service oriented or product producing. The quality o

GMP - FDA Compliance or Good Business Practices

July 24, 2018

Quality Systems Lab FDA Compliance or Good Business Practices?

What’s the most important aspect of having a Quality System? Is it to meet FDA compliance on a certain product you manufacture or to have a Quality System that benefits your entire

May 2, 2018

Do Asian Labs Also Have to Meet Dental Compliance?

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

Navigating Public Info for FDA compliance

September 27, 2017

How to Navigate Public Info on FDA's Website for FDA Compliance

FDA compliance begins with identifying if the products your business manufactures or imports are regulated. FDA Registration is one of the first steps necessary before placing medi

April 19, 2017

Using Your Dental Lab Quality System to Reduce Remakes

Making your customer happy is the goal of the dental lab. Customer complaints and remakes, both internal and external, are the nemesis to making the customer happy. Implementing FD