FEATURED EDITORIAL
The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America
Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.
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Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
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The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.
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MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
INDUSTRY INSIGHTS
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Beyond Visual Inspection: Understanding Acoustical Transparency As A PAT
Airborne ultrasound enables non-destructive seal monitoring, detecting subtle material variations. See how this proactive approach enhances consistency, reduces risk, and ensures packaging integrity.
Strategic fluidic partnerships simplify complex instruments through custom assemblies and intuitive fittings, reducing assembly errors, improving serviceability, and optimizing overall optofluidic system performance.
Composite sample probes combine metal precision with biocompatible thermoplastics, delivering rigid, high-tolerance performance and clean, inert flow paths for reliable biological sample handling.
Implantable systems offer precise, localized therapy, improving adherence. Overcoming biological barriers and surgical hesitancy remains essential for these technologies to achieve broad adoption.
Advanced inspection technologies are redefining implant packaging integrity, reducing risks and improving efficiency. Learn how these methods ensure sterility and elevate quality standards.
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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