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Standards and Compliance

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks...

The Rise of Time-Sensitive Networking (TSN) in Automobiles, Industrial Automation, and Aviation

Speed and determinism in design, made possible by time-sensitive networking (TSN) technology, is prompting the development of new TSN profiles for a multitude of applications across industry sectors. The IEEE 802.1™ Working Group of the IEEE Standards Association (IEEE SA) offers numerous TSN profiles for applications, including the automotive, manufacturing, and aviation industries.

Continuity and Change in International Wireless Approvals

On the 15th anniversary of his career in international product approvals, the author looks back on what has changed and what has remained the same in the global product approval process.

Preparing For and Implementing Product Recalls in 2022

Recalls are a major contributor to product liability incidents and lawsuits, interactions with government safety agencies, disputes with suppliers and product sellers, and negative publicity with the buying public. New guides have recently been issued that can help a manufacturer and product seller to better understand how to prepare for and implement an effective recall.

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...
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EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards...

FDA Updates List of Recognized Standards

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

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

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

Safety Programs and CPSC Mandates

Safety management programs are necessary to help a company make safe products and monitor safety for products in use. The CPSC has provided lots of guidances and mandates over the years on what constitutes an adequate program. These guidances are potentially useful to those companies seeking to establish a CPSC-compliant safety program and should be considered as part of the program development process.

FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than...
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