Standards and Compliance

Stay informed with standards updates, explore standards insights by topic, understand the importance of product liability, and learn international compliance best practices to ensure your products meet global regulatory requirements effectively.

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

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...

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NIST Releases Cybersecurity Discussion Draft

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

FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its...

FDA Posts Updated FAQs on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released an updated list of frequently...

Top 10 ISO/IEC 17025:2017 Deficiencies Found in Electronics Testing Laboratories

Whether your organization is seeking ISO/IEC 17025 accreditation for the first time or renewing a current accreditation, there are a few frequently overlooked or misunderstood sections of the standard to pay attention to.

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