Newsletter | March 12, 2026

03.12.26 -- MHRA Framework For Digital Mental Health

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Webinar: Demystifying AI In Modern MedTech

Discover how Battelle is helping MedTech teams turn AI potential into compliant, validated medical devices. In this practical, example-driven webinar, Technical Fellow Justin Sanchez and industry experts share real-world strategies to accelerate development while maintaining safety, reliability, and regulatory alignment. Gain a clear, accessible understanding of how AI delivers value across modern medical device development workflows, product lifecycles, and commercialization strategies. Click here to learn more.

FEATURED EDITORIAL

The U.K.'s MHRA Adds New Guidance To The Changing Regulatory Landscape For Digital Mental Health Technologies

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

Part II: Defining The Dye Ingress Operating Window

Learn about the viscosity-driven limits of dye ingress testing, translating qualitative constraints into a quantitative feasibility boundary shaped by defect size, pressure behavior, and plunger mechanics.

Achieve Leak Free And Safe Connections With Tubing Sleeves

Tubing sleeves simplify capillary connections, reducing leaks, dead volume, and complexity while providing reliable, high-pressure, and temperature-resistant solutions.

When Clean Is The Key To Precision

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink and precision rises, controlled environments are essential for success.

Selecting A Solenoid Valve In Health And Science Applications

Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.

ISO 10993-3: Major Updates In DART Evaluation

The updated ISO 10993-3 standard emphasizes a structured approach improving safety evaluations for endocrine disruptors and genotoxicity while reducing reliance on traditional animal testing methods.

RESOURCES

Radiology Solutions

Manufacturing With Specialized Material

Advanced Tubing Retainers: Pharma+

ARTICLES YOU MAY HAVE MISSED

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The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail

MES Is Still In The CD ROM Era But The Data Architecture Has Moved On

Accelerating Clinical Innovation With Open-Source Medical Platforms

Mastering Cultural Intelligence In Global Quality And Regulatory Leadership

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