A tough ruling for medical device manufacturers

Design considerations for medical device manufacturers.

As technology advances, so does the complexity of reusable medical devices. This creates greater challenges for cleaning, disinfecting, and sterilizing devices between patient uses. There is increasing concern from the U.S. Food and Drug Administration (FDA) and the reusable device industry that inadequately reprocessed devices are contributing to infections acquired in hospitals and other heal...

Assessing the FDA’s Cybersecurity Guidelines for Medical Device Manufacturers

MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software

Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional...

Association of Disposable Device Manufacturers

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Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

Objective To estimate financial payments from industry to US journal editors.Design Retrospective observational study.Setting 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014.Participants 713 editors at the associate level and above identified from each journal's online masthead.Main outcome measures All general ...