in Aircraft
China’s Next UDI Wave: A Practical Playbook for the 2027/2029 Expansion
Recent CPSC Civil Penalties and What We Can Learn from Them
ISSN 1948-8254 (print)
ISSN 1948-8262 (online)
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According to a Notice of Apparent Liability for Forfeiture (NAL), the three individuals operated two RF jamming…
The discussion paper, titled “Considerations for the Regulation of Generative AI-Enabled Medical Devices,” addresses…
n the increasingly complex world of electronic devices, electromagnetic interference (EMI) can pose significant challenges. EMI can disrupt the normal operation of electronic systems, leading to malfunctions, data corruption, and even complete system failures. EMI filters are essential components in the field of electromagnetic compatibility (EMC). They are designed to attenuate unwanted electromagnetic noise, ensuring that electronic devices function correctly and comply with regulatory standards. This article explores what EMI filters are, the different types available, practical tips for designing and implementing them, and their critical role in EMC.
ou did it! You designed some fantastic hardware, you passed all your EMC testing, and you got it launched. It’s been out in the field for some time now, and it’s time to make the next generation. Here’s the question: when do you need to re-test it for EMC?
This isn’t addressing the regulatory aspects of when you might be required to re-test a design. Instead, I’m addressing the technical standpoint: what technical changes might impact the EMC performance of a unit. I’ve had several conversations in my career that went something like this…
he trouble with aircraft and lightning began shortly after the start of powered flight. Some catastrophic issues occurred and, fortunately, many people survived these events. But research was needed to determine the cause of these problems created by lightning and find potential solutions.
But conducting the needed research also required obtaining data to create these models, and the data at the time required measurements on aircraft while being struck by lightning. Just the thought of flying an aircraft intentionally into a lightning storm to obtain this information requires a stronger constitution than I possess.
he current method of DC/AC analysis does not properly compute the DC input power to the inverter required to support electrical loads. The current methodology requires the DC power source be a battery or a fuel cell that can provide enough real power to the inverter to meet the load on the motor and this approach does not consider the reactive power component. What the theory is the DC power source must provide enough power to meet the motor apparent power needs and not just the real power needs. If the power calculations are inaccurate, then this will impact the battery powering the inverter and lead to improperly sized components and possible thermal issues.
A new power flow analysis is required to determine how much power needs to be provided to the inverter and motor, and a new approach is needed to compute component efficiency. A new method would provide a better understanding of losses and heat generation, which would also lead to a more robust electromechanical system.
f you sell medical devices into China, you’re about to enter the final stretch of China’s UDI (unique device identification) rollout. The newest announcements widen UDI coverage to the remaining device categories on a clear timeline: Class II devices and Class I IVDs in 2027, and Class I devices in 2029. That sounds straightforward – until you connect it to labeling, packaging hierarchies, regulatory submissions, database uploads, distributor workflows, and hospital usage.
This article gives you a practical, engineer‑friendly playbook. I’ll translate the policy into concrete actions you can take across product, labeling, IT, quality, and regulatory operations. I’ll also highlight where the announcements reduce effort (for example, when a product identifier update does not trigger a regulatory variation) and where they raise the bar (premarket database uploads and supply‑chain traceability expectations).
ince January 2023, the U.S. Consumer Product Safety Commission (CPSC) has assessed civil penalties against eleven companies for late reporting. I’ve written previously about the legal basis for these reporting requirements and will not repeat those in detail in this article.1 However, it is useful to examine the facts of each of these settlements so that companies can identify some of the triggers used by the CPSC to seek civil penalties.
In addition, I have previously written about the compliance programs required by the CPSC in settlement agreements entered into prior to 2022.2 Looking at the most recent settlement agreements will reveal the kinds of compliance programs that the CPSC currently likes to see companies have in place.
art 1 of this series introduced the ESD risks posed by 2.5D/3D chiplet integration and outlined the ESDA’s Class 1 and Class 2 framework, along with the contact-based CDM test methods currently being evaluated for Class 2 devices.
Beyond determining the contact-first CDM test method, other challenges remain for both Class 1 and Class 2 chiplets, some of which are even more critical for Class 1 chiplets. These additional challenges include…
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