Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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.
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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