(Michigan Metrology: Livonia, MI) -- Registration is now open for the Roughness, Texture, and Tribology class and workshop, which will be held in Livonia, Michigan, May 3–5, 2023. This class offers a unique opportunity to learn the fundamentals of surface roughness, friction, and wear, as well as the application of surface texture analysis in industry and research.

“This class is intended to help students to use surface roughness analysis in their workplaces,” says Don Cohen, Ph.D., who presents the course. “Live lectures and hands-on training with measurement equipment give our students a chance to ask questions and really learn what matters for their particular jobs.”

The class offers a deep dive into topics including:
• Measuring roughness and waviness
• Instruments for surface measurement
• Filtering texture data for the application
• Data analysis techniques and tools
• Surface texture parameters
• Specifying surface texture
• Applying surface texture analysis to wear, sealing, and other functionality
• Surface energy, adhesion, and texture, and paint appearance
• Mechanics of dry friction and rolling friction
• Fundamentals of lubrication
• Surface metrology strategy

(ETQ: Burlington, MA) -- ETQ, part of Hexagon, has announced the availability of an enhanced failure mode and effects analysis (FMEA) solution for use with its industry-leading Reliance NXG quality management system (QMS). ETQ developed the solution in partnership with Sandalwood, an engineering and ergonomics services firm with deep automotive expertise.

The AIAG-VDA FMEA software application helps automotive, aerospace, and other discrete manufacturer suppliers perform thorough risk analysis to predict and prevent failures in product design and production processes. The built-in framework ensures compliance with the harmonized international FMEA guide produced by the Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry (VDA). Adherence to the combined handbook is becoming a core requirement for suppliers doing business with many of the world’s largest OEMs.

The AIAG-VDA FMEA application is available immediately as an optional enhancement to Reliance NXG, ETQ’s cloud-native enterprise QMS platform. As with all Reliance applications, the enhanced FMEA is flexible and configurable to meet specific customer requirements, and integrates with related quality processes like corrective and preventive actions and nonconformance reporting.

Updated 12/12/22

At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On the table will be the possibility to extend the deadline to 2027 for higher-risk devices and 2028 for lower-risk devices. 

The European Commission had come under increasing pressure to extend the deadline after EU member states, notified bodies, and medical device companies told the commission that it would be impossible for all medical devices currently approved under the old medical device regulations to transition to the newer regulations by the May 2024 deadline. This was something the Commission’s own studies were bearing out.

This is good news for the medical device community and the EU healthcare system. 

Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes are also high in healthcare, because cybersecurity risks can expose or hinder access to electronic protected health information (ePHI) or even harm patients if the equipment malfunctions or is inaccessible.

Medical device cybersecurity hinges on knowing the vulnerabilities of each device and whether patches are available, as well as how critical each piece of equipment is to the overall function—and determining any risk to patient safety, among other factors. Continuous assessment and real-time risk measurement help prioritize surveillance efforts, raise red flags, and mitigate risk efficiently.