FEATURED EDITORIAL

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.
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Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.
INDUSTRY INSIGHTS
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Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials
Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.
A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.
A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.
Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.
A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.
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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