Newsletter | July 5, 2025

07.05.25 -- June's Most Popular Articles & Solutions

FEATURED EDITORIAL

AI In Medical Devices: Meeting The Regulatory Challenge Around The World

This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.

China's Medical Device Market: A Land Of Opportunity And Challenges

Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in China.

Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

TOP INDUSTRY INSIGHTS

The Ultimate Guide To Biological Indicators

Discover why biological indicators are the gold standard for sterilization validation in pharmaceutical and medical device manufacturing, as well as how choosing the right one ensures safety.

Turning PFAS Challenges Into Opportunities

Medical device makers face growing global pressure to eliminate PFAS. Embracing circular design and innovation offers a path to compliance, sustainability, and supply chain resilience.

The 5 Ws Of A Human Factors Strategy

A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

TOP RESOURCES

Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success

An Introduction To Validation Of Aseptic Fill/Finish And Related Processes

Smart Pump Module

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