FDA 510(k) Consulting

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

FDA clearance is critical to your market success. 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.

Ask us about our “3-Step Kick-Off" for FDA 510(k) Consulting.

1. In-depth review of your overall regulatory strategy and determination of how the project will align with your business objectives
2. Screening of your 510(k) documentation to identify compliance gaps
3. Development of a project plan; confirmation of the specific deliverables

Intertek consulting services provided for medical devices are carried out by medical device experts who have no influence over any aspect of Intertek Notified Body activities.