FEATURED EDITORIAL

Conventional medical devices have revolutionized patient diagnostics and treatments. The future is heading rapidly toward a point where advanced software such as data science and AI techniques are driving a new wave of innovation and positive health impacts.
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The previous two articles in this article series covered what to do before and during medtech trade shows. In this last article of the series, the author describes the activities to set up after the show in order to maximize your results, including organizing a post-show team debriefing and measuring your results.
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The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
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As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.
INDUSTRY INSIGHTS
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Change Control: Considerations For Medical Device Components
Explore the various factors that must be considered when faced with such modifications, and what processes must be implemented in advance as part of a robust Quality Management System.
As demand for high-efficiency and high-power-density inverters continues to grow, the so-called “flying” capacitor multilevel inverter is emerging as a strong choice for many power electronics systems.
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Learn about the CCI testing of biologics along with effective test methods.
Raghu Vadlamudi, Chief Research and Technology Director of Donatelle, introduces trends medical device manufacturers need to be prepared to adopt in order to create next-generation medical devices and components.
MED DEVICE ONLINE CONTENT COLLECTIONS

Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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