Newsletter | January 10, 2026

01.10.26 -- December's Most Popular Articles & Solutions

FEATURED EDITORIAL

Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

Wearable Medical Devices — What Should Your Contracts Look Like?

Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the outset.

Accelerating Clinical Innovation With Open-Source Medical Platforms

Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, researchers, and patients.

TOP INDUSTRY INSIGHTS

ISO/DIS 10993-3 Updates: A Focus On DART For Medical Devices

Revisions to ISO 10993-1 and -3 emphasize a risk-based approach, lifecycle considerations, and a shift from biological testing to comprehensive evaluation for endpoints, impacting testing requirements.

A Pathway For Regulatory Success For Devices In Combination Products

Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

PolyPeel Peelable Polyester Heat Shrink Tubing

PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is designed to overcome PET’s shortcomings.

TOP RESOURCES

Characterization & Delivery Of Ultra-Viscous & Non-Newtonian Formulations

ComfortCoat Single Layer Coating For Vascular Interventions

Medical Device Technical Due Diligence

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