Medical Device Regulations & Compliance


EKG-Heartbeat-Flatline-Dead-iStock-177096054 AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies

Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.

  • The Medical Device Excise Tax Is A Disaster!

    Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), recently issued a statement in response to President Trump’s State of the Union Address, "While the passage of an additional two-year suspension of the medical device tax is a recognition of how important it is to bolster America’s leadership position in this industry, Congress must permanently repeal this disastrous policy in order to fully realize the long-term investments in patient care and job creation that are critical to growth.” Did he really say – disastrous? Oh yes he did!

  • I Said “No.” Management Said “Yes.” FDA Said “Recall.”

    At most medical device companies, mere utterance of the word recall is akin to mentioning the Dark Lord’s name in the Harry Potter series of novels: it’s simply not done, unless one wishes to invite misfortune upon oneself. In Harry Potter’s world, the Dark Lord (Voldemort) is referred to as “He-Who-Must-Not-Be-Named,” a moniker easily coopted by “recall”-averse medical device companies into “That-Which-Must-Not-Be-Said.”