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FDA Compliance and Consultants

SafeLink Consulting provides guidance in not only complying with the FDA requirements, but also helping you to infuse and maintain a quality atmosphere throughout your organization.

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Having an effective Quality System will ultimately aid your business in operating more efficiently and becoming more profitable. Attempting to setup and maintain a Quality Management System on your own can cost your business a lot of valuable time and money. Eliminate unnecessary costs, headaches and frustration by contracting SafeLink to establish and manage a program for you. Gain peace of mind knowing your business has a reliable, Quality System in place that not only meets FDA’s Quality System requirements, but ultimately can increase your bottom line.

Our Extensive Quality Program delivers the most comprehensive plan available to assist you in development of a Quality System that follows FDA’s Title 21, Chapter I, Subchapter H – Medical Devices, Part 820 Quality System Regulation. This service includes determination of your appropriate level of compliance. Your SafeLink consultant will address the issues specific to your business regardless of size and coach you on how to ensure all required quality management system elements are identified, scaled appropriately to meet compliance requirements, and effectively implemented. Our goal is to help you cultivate and maintain a quality system that is viable.

SafeLink Consulting can become a part of your Quality Team by providing quality management onsite monitoring. This service can cover the entire Quality System or be limited to certain components of the Quality System such as Complaints, Remakes, and Internal Reworks. The initial visit is typically five days and then followed up with visits every month for a minimum of 2 days.

Either through our onsite visits or workshops, we will teach you how to ensure all required quality management system elements are identified and effectively implemented. Onsite visits include preparation of customized documentation with follow-up by phone calls and emails. Should you hear from an FDA inspector, we’ll provide you with the guidance you need.

SafeLink Consulting Can Help You:

  • Save valuable time - we investigate the complicated FDA Quality System Regulations for you thus saving you hours spent from having to tediously research and understand it on your own
  • Perform more efficient processes
  • Strengthen communication skills with your customers and staff
  • Respond to FDA if you receive an inspection
  • Save you money - by contracting us at a fraction of the cost of hiring additional in-house staff to assist you with your quality assurance program
  • Increase your productivity
  • Minimize citations/fines in the event you are inspected by FDA
  • Help you stay on track

SafeLink provides onsite, face-to-face consulting and follow up to help you comply with FDA requirements. For more information on our FDA consulting services, please contact us today for a quote.

What is a Quality System and Good Manufacturing Practices (GMPs)?
(Dental Regulations)

About Safelink Consulting

SafeLink presenters are nationally recognized for providing workshops and seminars to diverse audiences. Through onsite visits, seminars, and Webinars SafeLink’s presenters have successfully trained thousands of our clients’ employees on safety and quality management.

  • Address: 327 Dahlonega Street, Suite 601A
    Cumming, GA 30040 USA
  • Phone: (770) 205-6745
  • Email:
  • Monday - Friday: 9:00 am - 5:00 pm
    Saturday - Sunday: Closed
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