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Standards and Compliance

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.

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.
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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.

How Do You Compare ANSI/ESD S20.20 and MIL-STD-1686?

Confusion is created when there is more than one standard to define requirements. For ESD control, this has been the case with a military standard (MIL‑STD‑1686) and ANSI/ESD S20.20.

Australian Radio Communications, EMC and EMF Regulatory Requirements: A Primer

Wireless devices are now in the legislative spotlight the world over. Safety, performance, spectrum usage and protection of personal data are all matters of regulation, although countries vary in how they regulate such concerns. This article looks at Australia as a case study, reviewing the overarching legal framework, the role of the national regulator, conformity assessment and the use of standards.

U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has...
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