Statement from EMMA International In Response to the Netflix Documentary “The Bleeding Edge”

Jul 30, 2018

As a quality and regulatory consulting firm in the Life Sciences space, we work with innovators, product developers, and manufacturers of medical devices. Given the nature of our work and involvement in the Medical Device industry, we find this documentary to be disappointingly biased. By leveraging a platform such as Netflix, “The Bleeding Edge” is a catalyst to invoke unjust fear and anxiety in individuals who are unfamiliar with the rigorous regulatory and quality channels medical devices go through prior to being available to patients. Our concern is that this film might influence a patient from the advantages of a safe medical device that could benefit their health. In turn, this could possibly result in health deterioration or death.

This documentary has singled out a handful of cases with adverse outcomes and excluded the millions of people who are experiencing an increased quality of life due to advancements in medical devices. This film inaccurately portrays the rigorous regulatory pathways that medical devices go through to ensure patient safety. In our direct work assisting medical device firms with FDA clearance, we know from firsthand experience that the FDA is the gold standard in patient safety on the global front.

“[The Bleeding Edge] uses a fear tactic of cherry-picking patients with adverse outcomes to market to a population of viewers who are unfamiliar with the FDA landscape. This documentary does a disservice to patients whose lives would benefit from medical devices”, said Dr. Carmine Jabri, President/CEO of EMMA International.

About EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

For more information, visit If you would like additional information, please contact Kira Jabri at 248-987-4497 or email at

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