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The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...

In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices. But several years earlier, government officials recognized the risk: Soon after the FDA made its ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Because it is getting harder to underestimate "the evil genius of the modern-day cybercriminal," Eracent, which develops asset management tools for software and IT, says it will offer healthcare ...

Medical device and software maker Zoll Medical Corp. has disclosed that it has suffered a data breach that resulted in the possible theft of records belonging to about a million people. A division of ...

Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...