Quality Management System
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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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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Maximize Your LMT Lab Day East Experience with SafeLink Consulting
Discover how SafeLink Consulting's seminar at the Annual LAB DAY East can elevate your dental lab's compliance and safety standards.
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SafeLink's Gary Morgan Returns to NADL University to Teach Quality Assurance & GMP
SafeLink Consulting is proud to share that Gary Morgan, CDT, CQA/ASQ our Senior Vice President & Partner, will once again be leading a core session at NADL University this Septembe
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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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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 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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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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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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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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The Real Cost of a Workplace Safety Program and Its Hidden Value
Health and Safety programs tend to be one of the last programs businesses invest in during a major growth stage. Furthermore, for a management team in cost-savings mode, Health and
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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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