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FDA Releases Catalog of Regulatory Science Tools for Medical Devices

To facilitate the expanded use of innovative science techniques in the development of new...

FDA Posts Biocompatibility Resource Center

The U.S. Food and Drug Administration (FDA) has collected a variety of resources to...

MIL-STD-464D: A Review of Recent Changes

In this article, we detail the key changes between MIL-STD-464C and MIL-STD-464D, the recently-released update to the standard.

UK Passes Post-Brexit Medical Device Regulation

Moving to partially allay uncertainty regarding the approval of medical devices for use in...

FDA Modifies List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...
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FDA Provides Update on ASCA Testing Laboratory Accreditation

The U.S. Food and Drug Administration (FDA) says it will release within the next...

FDA Names First Acting Director of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has appointed its first Active Director of...

Keep your iPhone 12 Away from Medical Devices, Apple Says

iPhone maker Apple is cautioning certain users of its iPhone 12 models to be...

Applying ISO 26262 to Power Management in Advanced Driver Assistance Systems

Are you a new safety manager shopping power converters and wondering about the features listed under the functional safety section? Or are you a seasoned design and release engineer looking to start on a new ISO 26262 module? Either way, this article offers guidance in applying functional safety concepts to your next automotive design.

FDA Sets Action Plan to Regulate AI in Medical Devices

The U.S. Food and Drug Administration (FDA) has released its plan for regulating certain...
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