FDA Compliance
What Every MedSpa Patient Has the Right to Know
This patient safety guide is co-authored by VIO Franchise Group and SafeLink Consulting. Before you book. Before you consent. Before anyone picks up a needle, laser, or device. The
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Dental 3D Printing Compliance: Is Your Dental Practice at Risk?
Dental 3D printing has made chairside care faster, more precise, and more profitable. What most dentists don't realize is that the technology also brought four new sets of federal
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Dental Lab Compliance: What It Takes to Keep a Government Contract
For dental labs, landing a government contract with the VA or another agency feels like a major milestone. But for one California dental lab, that opportunity quickly became a cost
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Medical Spa Compliance - Under the Microscope
The medical spa industry has exploded over the past decade — and regulators have noticed. What was once a gray zone between day spa and medical clinic is now firmly in the crosshai
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Maximize Your LMT Lab Day West Experience with SafeLink Consulting
Discover how SafeLink Consulting's seminar at the Annual LAB DAY West can elevate your dental lab's compliance and safety standards.
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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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The Risk & Compliance Paradox: Why Dental & Healthcare Organizations Are Overtrained Yet Under-Supported
In the complex world of healthcare risk & compliance management, a troubling pattern has emerged across dental labs, dental practices, medical offices, and small health and wellnes
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Maximize Your LMT Lab Day Experience with SafeLink Consulting
Discover how SafeLink Consulting's seminars at the 41st Annual LAB DAY Chicago can elevate your dental lab's compliance and safety standards.
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Mastering the Basics of Quality Assurance at NADL University
Transform your career at NADL University where SafeLink Consulting is proud to present the Quality Assurance Systems and Good Manufacturing Practices course. Join us September 18 -
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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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SafeLink Presents NADL Fall Daze Virtual Education Course Oct 24, 2025
Discover how prioritizing OSHA and FDA compliance can boost productivity and profitability in your lab. Don't miss out on the opportunity to delve deeper into this topic with Gary
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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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Fire Prevention in the Workplace - How to Use Fire Extinguishers
Are you prepared to handle Fire Emergencies in your workplace? Fires are probably more common than you may think. The NFPA reports that fire departments respond to a fire on averag
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Be an Asset Rather Than a Risk as a Supplier or Subcontractor
It is not unusual today for a medical device manufacturer to outsource components of their production to third party subcontractors or suppliers. The subcontractor or supplier is r
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Enhance Trust in Your Supplier Management Process to Reduce Risk
Medical device manufacturers, including dental laboratories, must implement a supplier management process to comply with FDA's quality management system regulations. They must ensu
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Top Ten Quality Mistakes - Part Two
Learning from mistakes, whether our own or others', is a valuable way to improve. In this article, I aim to highlight the top ten quality mistakes often made by businesses and prov
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Top Ten Quality Mistakes - Part One
Since many of us seem to learn better from our own mistakes or the mistakes of others, I’d like to share with you some common top ten quality mistakes made by businesses and how yo
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SafeLink Presents Regulatory Standards Courses at WSDLA 2024 Conference
SafeLink Consulting's Gary Morgan, CDT, CQA/ASQ, presents two courses on regulatory standards at the WSDLA Conference in Seattle-Bellevue March 8 - 9, 2024.
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FDA Amends 21 CFR 820: Announces QMSR
The wait is finally over! On January 31, 2024 FDA issued the Quality Management System Regulation final rule. "The FDA is amending the title of the regulation, and establishing req
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SafeLink Consulting & Grand Avenue Present eQMS Dental FDA Compliance
SafeLink Consulting is pleased to announce its new strategic relationship with Grand Avenue Software, a leading provider of electronic quality management systems, or eQMS tools for
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Reflecting on Dental Compliance in 2023 and Looking Ahead to 2024
2023 has been filled with challenges for us and for our clients, but here we are in 2024 anticipating what this new year will bring and ready to meet the expectations of our client
Read more → Quality Assurance / FDA Dental Review 2023 and Outlook 2024
As we step into the year 2024, it's important to reflect on the challenges we faced in 2023 and the determination we exhibited alongside our clients. With a brand new year ahead of
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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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Urgent FDA Recall: Saline and Sterile Water Products Alert
On November 6, 2023, the U.S. Food and Drug Administration (FDA) informed the public of a recall affecting certain brands of saline and sterile water products. This recall holds si
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SafeLink Presents Regulatory Compliance at Whip Mix Digital Forum
Come and be a part of the 11th Annual Whip Mix Digital Forum, where SafeLink Consulting is proud to present a regulatory compliance course. Join us on September 15th and 16th in th
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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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Gary Morgan, CDT, CQA/ASQ Receives NADL Merit Award
Congratulations to Gary Morgan, CDT, CQA/ASQ, on being presented the NADL Merit Award for Outstanding Achievements at the 2023 NADL Vision 21 Meeting in Las Vegas. Gary was present
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Is ISO 13485 a Requirement for the Dental Laboratory?
As you may be aware, the Food and Drug Administration announced a couple of years ago that it would be making changes to the Quality System Regulation (CFR Title 21 Part 820). This
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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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OSHA First Aid Requirements
In the event of an injury, are you complying with OSHA's requirement to provide a first aid kit, and to train an employee to render first aid? Most businesses do not understand how
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National Preparedness Month - Emergency Preparedness Plan Guide
The National Safety Council and the U.S. government recognize September as the official National Preparedness Month in the heart of Hurricane season. If you don’t live in a hurrica
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How Does CDC's No Mask Required for Those Vaccinated Against COVID-19Affect Dental Employers?
CDC announces that those of us who have completed our COVID-19 vaccination and the two weeks after the final vaccine do not need to wear a mask inside or outside. So how does CDC's
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Washington State Passes Health Emergency Labor Standards Act - HELSA
The state of Washington has published an announcement about the recently passed Engrossed Substitute Senate Bill 5115, known as the Health Emergency Labor Standards Act (HELSA). Go
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Creating Proactive Regulatory Compliance Programs for the Dental Lab
Your business may need to be compliant with many regulatory requirements issued by agencies like OSHA, FDA, EPA, Health Agencies and State Dental Boards. Being proactive is key to
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Dental Labs Could Receive FDA Remote Assessment Request
FDA is trying out a new procedure in lieu of an onsite audit during the pandemic. Dental laboratories may receive a letter from FDA requesting them to participate in a compliance a
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What Role Does Your Quality System Play in this COVID-19 World?
The answer is “A very important one”. Some are referring to this stage of our business lives in having to deal with the challenges of a pandemic as “disruptive change”. I’m sure ma
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Qualifying Alternate Vendors - Why It Is So Important!
There have certainly been some tough lessons learned from the current pandemic. For a lot of businesses, a primary takeaway is how planning ahead and having a secondary resource fo
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Is Your Dental Lab Doing Business in Canada or Considering It?
U. S. and Canadian medical device requirements for dental laboratories are not the same. Whether your dental lab is considering doing business or already doing business in Canada y
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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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