Other content on this topic
Medical Device Security Needs a Lifecycle Approach
INTRODUCTION: The widespread connectivity of electronic products to the Internet, including medical devices, creates an ever-increasing opportunity for cyber-attacks and possible...
Reducing the Risk of the Software Supply Chain in Medical Devices
INTRODUCTION: Medical devices rely on third-party and in-house existing software as needed, to meet functionality, cost, and time-to-market concerns. Although software of unknown...
The Role of Static Analysis in Management of Cybersecurity in Medical Devices
INTRODUCTION: The FDA, recognizing the need for more robust security in medical devices, issued its guidance on managing cybersecurity in 2014. The growth of wireless, networked, and...
FDA Post-Market Static Analysis of Medical Device Software
INTRODUCTION: Software in medical devices ideally provides better functionality, usability and safety. However, software is complex and prone to errors. The Federal Drug Administration (FDA)...
Static Analysis and IEC 62304
INTRODUCTION: The IEC/ISO 62304 standard defines a risk and quality driven software development process for medical device software. The standard emerged from a recognition that...
FDA's Use of CodeSonar® Detailed in Embedded Systems Design
Embedded Systems Design today published an article co-authored by Raoul Jetley of the FDA and GrammaTech's Paul Anderson, titled "Using static analysis to evaluate software in...