FDA 510(k) Consulting

Preliminary Guidance for Building a Successful FDA 510(k) Submission

FDA clearance is critical to your market success and Intertek will help you navigate the 510(k) submission process quickly and efficiently. 

Missing information and deficiencies in your 510(k) submission can lead to failure and may delay your product launch by months. Intertek Consultants provide one-on-one preliminary guidance for your 510(k) submission, helping you shorten your certification process and get to market on time. Our lead consultant has worked directly with FDA branch chiefs and reviewers, which translates into extensive product knowledge and industry experience passed on to you throughout your 510(k) submission review.

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Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.


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