Data Management Laws Manufacturing 
FDA Law Blog
DECEMBER 12, 2022
If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device. Clinical Decision Support Software.
FDA Law Blog
JANUARY 5, 2023
It emphasizes building partnerships with local health and law enforcement authorities, so organizations can mitigate any breaches, especially those that can potentially cripple smaller, less resourced providers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
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The Crime Report
APRIL 21, 2022
It calls for changes in state laws and policies to support the expansion of the practice. borders; improving data systems and research that guide drug policy; and making sure the people most in danger of overdose can get evidence-based treatments, including people experiencing homelessness and those in prison or jail.
The Process Street
OCTOBER 4, 2021
This isn’t always the simplest task, however – particularly in today’s knowledge economy where the value of human capital is a much more complex issue than in an industrial or manufacturing-based economy. Data management. Change management. Stakeholder management. Data & infrastructure.
FDA Law Blog
JUNE 12, 2022
established by statute and case law. The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . This fraudulent inducement theory is well?established
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