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Standards and Compliance

ISO/TS 20559: A Systems Approach to Safety Communication

This new international specification focuses on workplace safety sign systems. Yet many of its underlying concepts speak to various forms of safety communication meant to reduce risk in today’s world – including product safety labeling.

FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

FDA Issues Guidance on ISO 10993-1 for Medical Device Biological Evaluation

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the...

FDA Issues Guidance on Recognition of Voluntary Consensus Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance on how the...

Why Resistance Requirements Differ by Industry and Why Standards Matter

Confusion over ESD flooring resistance terminology and requirements abounds, leaving many in the dark and creating potential risks. This article helps to clarify this complicated issue so that you can work to mitigate the problem.
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FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing...

Safety Considerations for Lithium and Lithium-Ion Batteries

This article provides an overview of current standards applicable to rechargeable lithium and lithium-ion batteries.

Challenges and Directions for Lifecycle Processes Supporting Conformity Assessment of Interoperable Medical Products

This article provides an overview of lifecycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards and identifies lifecycle concepts from other domains that may be adapted for interoperable medical systems.

Product Liability Litigation and its Effect on Product Safety Regulatory Compliance

Product liability litigation and product safety regulatory compliance are sometimes intertwined, and this can make a bad situation worse.
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