UserWise assists clients in following the FDA-prescribed Human Factors process in its entirety. Once the product is ready for FDA submission, we compile a Human Factors Submission Package that meets FDA expectations to the letter. Our goal is always to have zero questions from the FDA about Human Factors, which signifies an expedient review cycle.
Shockwave Medical is a great example of one of our very successful 510(k)s!
Shockwave Medical Announces FDA Clearance Of The Company's Lithoplasty System, The First And Only Technology To Use Sound Waves To Treat Calcified Peripheral Artery Disease
Read the full paper here!