Insights & Analysis
Expert perspectives on ENDS device engineering, regulatory strategy, and intellectual property from over 20 years of industry experience.
A comprehensive guide to Chemistry, Manufacturing, and Controls documentation requirements for Pre-Market Tobacco Applications. Learn the key elements FDA reviewers focus on.
From early cigalikes to modern pod systems, explore how device architecture has evolved to improve user experience, safety, and regulatory compliance.
Understanding how FDA warning letters arise, what they typically reflect about compliance posture, and how ENDS manufacturers can approach response and remediation.
Independent engineering context on the relationship between coil resistance, metal concentrations, and device design factors in ENDS aerosol generation systems.
Implementing robust design control processes for nicotine delivery systems to ensure regulatory compliance and product quality.
Engineering challenges and solutions for heat dissipation in modern ENDS devices. Balancing performance, safety, and form factor.
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