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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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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Does the OSHA ETS Published June 2021 Apply to Your Dental Practice or Lab?
Since CDC's Guidance was issued on May 28, 2021 and OSHA's Emergency Temporary Standard for healthcare became effective on June 21, 2021, SafeLink Consulting has received questions
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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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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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COVID-19 Safety & Infection Control Guidance for Dental Practices
Dental practices must ensure that their infection control procedures and policies are working to protect their workers. Here you'll find some helpful Q&A from SafeLink Consulting's
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COVID-19 Safety & Infection Control Guidance for Dental Labs
Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system
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Managing Risks of COVID-19 in a Dental Laboratory Setting
The pandemic of the Coronavirus Disease 2019 (COVID-19) has created real challenges and uncertainties for businesses around the world. Needless to say, all of us at SafeLink Consul
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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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Workers Are At Risk Without Enforcement of Safety Compliance Program
Ever wonder why OSHA is really necessary? Take a look at these examples of employees being placed at risk. On my recent visit to China I was able to capture some examples of why th
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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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