FEATURED EDITORIAL
Conducting A Medical Device Stability Study: A Practical Guide
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
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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.
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The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies qualify as medical devices based on their intended purpose and functional impact.
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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