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 ...

From concept to clinical use, medical device safety depends on proactive risk management. Tools like FMEA help teams identify and prioritize potential failures before they cause harm. Combined with ...

Risk management is defined as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, and controlling risk, according to Kimberly Trautman, ...

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 ...

Risk Management is a vital component to developing and designing medical devices. Before your product goes to market, you have to know that it is safe and that you've analyzed and mitigated every risk ...

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, ...

NEW YORK , Feb. 21, 2024 /PRNewswire/ -- Beyond Identity, the leading provider of passwordless, phishing-resistant MFA, today announced the release of its new Device360 solution for continuous device ...

MITRE’s April 2026 analysis warns that cloud-based medical devices could cause cascading patient care disruptions if a single provider is hit by ransomware. The shift to cloud-native designs creates ...

This course is intended for professionals of all experience levels interested in the techniques of risk management as applied to product safety for medical devices. Risk management is a process for ...