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 ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
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 ...
The new Medical Device Product Security Intelligence Platform from Medcrypt, of San Diego, CA, is designed to help medical device manufacturers (MDMs) evaluate their product's security posture, ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
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 ...
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 ...
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