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.
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
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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
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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
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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
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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
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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
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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
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7 Steps to Successfully Navigating FDA Renewal Registration
If your facility is FDA registered, October 1 marks the start of a crucial renewal period. It is imperative to complete the renewal process by December 31 to maintain an active reg
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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
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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
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The Value of Writing Standard Operating Procedures (SOPs)
The basis for all quality management systems is to establish standardized processes throughout the organization that produce consistent desired results. Virtually every responsibil
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Reviewing Your Facility's FDA Registration
Has your business been registered with the FDA? Have you updated your registration for the new year?
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Tips for FDA Registration Renewal
Don't forget to complete your FDA registration renewal before the end of the year if your establishment is registered with FDA. The renewal period runs from October 1 to December 3
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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
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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
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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
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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
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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
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