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. Senate has introduced a bipartisan measure that would help to ensure the...

FDA Clarifies Cybersecurity Recommendations for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that...

EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU)...

FDA Warns of Medical Device Cyber Vulnerabilities

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device...

FDA Releases Final Guidance on Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help...

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Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the...

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat...

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What's New

Military and Aerospace EMC: High Intensity Radiated Fields (HIRF)

FDA Issues Digital Health and AI Glossary

FCC Clarifies Satellite System Spectrum Sharing Rules

Practical Engineering: Using Welch-Satterthwaite Formula in Uncertainty Analysis

FCC Enforcement Bureau Convenes Regulators to Discuss Emerging Trends

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Standards and Compliance

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What's New

Military and Aerospace EMC: High Intensity Radiated Fields (HIRF)

FDA Issues Digital Health and AI Glossary

FCC Clarifies Satellite System Spectrum Sharing Rules

Practical Engineering: Using Welch-Satterthwaite Formula in Uncertainty Analysis

FCC Enforcement Bureau Convenes Regulators to Discuss Emerging Trends