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Standards and Compliance

FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

NIST Releases Cybersecurity Framework 2.0 Draft

The National Institute of Standards and Technology (NIST) has recently published for public comment...

FDA Updates List of Recognized Standards

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

The Legal Perils of Customer Service

Customer service, before and after sale, is one of the most important functions that must be performed by a manufacturer or product seller. It is also one of the riskiest. Obtaining no information, inadequate information, wrong information, misleading information, or harmful information can make it difficult to evaluate future risk, meet your regulatory obligations, and defend a product liability lawsuit.

FDA Issues Guidance on Qualification of Medical Device Development Tools

The U.S. Food and Drug Administration (FDA) has published its final Guidance on the...
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FDA Announces eMDR Enhancements

The U.S. Food and Drug Administration (FDA) has posted a list of pending enhancements...

ANSC C63 Committee on EMC: A 2023 Status Report

This article is intended to cover recent operations of the ANSC C63 Committee, including an announcement of a Chairmanship change and detailed descriptions of the most recently released C63 Standards.

NIST to Lead Standard Development for Critical and Emerging Technologies

The U.S. National Institute of Standards and Technology (NIST) has detailed its plan for...

FDA Releases New Video on Cybersecurity in Healthcare Facilities

As part of its effort to protect healthcare workers and patients from equipment malfunction...

NIST Releases Cybersecurity Discussion Draft

The U.S. National Institute of Standards and Technology (NIST) has recently published a discussion...
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