Newsletter | August 26, 2025

08.26.25 -- The 2025 FDA Enforcement Wake-Up Call

FEATURED EDITORIAL

The 2025 FDA Enforcement Wake-Up Call

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.

INDUSTRY INSIGHTS

Achieving EU GMP Annex 1 Compliance For Contamination Control

Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

New Tool Measures 4 Surface Appearance Quality Conditions Simultaneously

Discover a manufacturing-friendly tool to set numerical standards and measure gloss, haze, image clarity, BRDF, and Canon’s new “Scattering C20, C60” parameter.

Adapting To USP 382: Enhanced Testing For Parenteral Packaging

USP 382 introduces system-level, function-specific testing for elastomeric components in parenteral packaging, improving container integrity, sterility, and patient safety through enhanced protocols.

How Variable Volume Pumps Work

Understanding the intricate processes of variable volume pumps, particularly in aspirating and dispensing, is crucial for optimizing precision and accuracy in fluid control systems.

Comparing “Apples To Apples” With Your Med Device Injection Molding RFQ's

Navigating RFQs in medical device injection molding requires scrutiny beyond pricing. Explore crucial considerations for transparent partnerships and cost-effective solutions.

RESOURCES

BioTight Fitting

Medical Balloons

Medical Device Solutions Fact Sheet

ARTICLES YOU MAY HAVE MISSED

Improving Drug-Device Combination Product Co-Development

Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

Medical Device Innovation In Brazil: Success Stories And Future Opportunities

Audit Trail Compliance And What To Look For In Mitigation Software

Connect With Med Device Online: