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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Missing information and deficiencies in your 510(k) submission can lead to failure and may significantly delay your medical device product launch. This course is designed to provide an overview of the FDA’s medical device regulations and teach you how to prepare your 510(k).
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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.
