Harvey Rudolph Underwriters Laboratories Inc. A popular catchphrase these days is risk management. It is being used by regulators worldwide, as well as by standards developers and others whose ...

In today’s highly connected world of healthcare, medical devices have become fully integrated elements of patient care and treatment. But a high scale of deployment also brings greater exposure to ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

Long-life medical devices - products typically used for a decade or longer - are among the most post-quantum, cryptographically vulnerable technologies in ...

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 ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

Weak authentication for medical devices (or a lack of it) has become a sweet spot for cyber criminals. Hackers accessed 1.2 ...

Supply chain leaders and managers in the medical device industry are often puzzled by the multitude of strategies, corporate directives, and transformation programs that claim to improve the ...