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Standards and Compliance

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.

Location of Safety Warnings

This article discusses the legal and practical issues around the duty to warn and instruct and where to place safety information on the product and/or in the manual.

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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EU Commission Opens Options for Remote Audits for Medical Devices

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union...

FDA Launches Its Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) has launched a voluntary program to help...

The EU Conflict Minerals Regulation

This article discusses and contextualizes the EU Conflict Minerals Regulation for the electronics sector. While electrical equipment manufacturers that place products on the EU market are not specifically targeted under the Regulation, the law applies to them if their operations involve importing conflict-implicated metals and minerals into the EU (e.g., for use in manufacturing their products). Regardless, the Regulation raises implications for any electrical equipment manufacturer that distributes and sells products in the EU, specifically when it comes to publicly reporting on uses of conflict minerals. The EU’s proposed “transparency platform” is detailed in this regard.

Standards Play A Key Role In Enabling Innovation

Standards play a critical role in enabling new technologies to go mainstream faster while freeing customers to choose best-of-breed solutions from multiple vendors. Here’s what vendors need to know about why and how to participate in standards-related processes, including conformity assessment activities.

Robots and Robotics

The use of robots and robotics is becoming more common across many industries. As these devices become more common and their use grows, manufacturers must understand the hazards they present, regulatory requirements, and testing options.
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