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FDA 510k Consultants

Are you a manufacturer of medical devices?

Are you current with the latest FDA 510(k) news? A FDA 510k is the section of the Food Drug and Cosmetic Act that requires device developers to notify FDA of their intent to market a device through submission of a Premarket Notification. Class I, II or III medical devices that do not require Premarket Approval can be placed on the market, but they must still be cleared by the FDA prior to marketing and distribution.

Companies intending to introduce certain classes of medical devices into the US market must submit a 510(k) to the FDA. After FDA’s clearance that medical device can be manufactured and distributed in the US. Changes in technology used to manufacture a device or a change in the intended use of the medical device can also require submission of a 510(k) premarket notification to FDA. 

At SafeLink Consulting, we will assist you to determine if your business model meets this requirement. If not, our compliance services go above and beyond just the 510(k) submission process. We have been providing compliance services for over 20 years. SafeLink’s FDA compliance consultants will consult with your business and your team members throughout each compliance order.

Learn more about FDA 510k for the Dental Lab or Dental Manufacturer.

To learn more about our guidance process or to see how SafeLink Consulting can improve your organization’s quality system, contact us or call 800-330-6003.

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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.

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  • Phone: (770) 205-6745
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    Saturday - Sunday: Closed
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