Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality

Assessing the FDA’s Cybersecurity Guidelines 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...

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...

Optimal Control of Software Ensuring Safety and Functionality

Existing verification and validation methodologies can detect software violations very effectively but fail to provide any mechanism for correcting faults once they are detected. Detection of faults, their diagnosis and corrective actions are all essential components of any software rectification framework. In this paper, we propose a framework for correction of violations in software systems e...

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 ...