Newsletter | March 12, 2024

03.12.24 -- New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

FEATURED EDITORIAL

New FDA QMSR Through The Lens Of Risk Management

On February 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by February 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

INDUSTRY INSIGHTS

The Chemistry Of Aqueous Cleaning

In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

What Is Micro 3D Printing?

Micro 3D printing, also called micro additive manufacturing, produces printed parts at the micron level. Explore the advantages of micro 3D printing and how it compares to nano printing.

Single Source Partner: Seamless Approach To Deliver World-Class Treatment

Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements. 

How Fluids Impact Variable Volume Pump Performance

Explore the factors influencing variable volume pump performance, from fluid viscosity and temperature to chemical compatibility and flow stability, ensuring reliable operation and system longevity.

ARTICLES YOU MAY HAVE MISSED

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

Understanding Australia’s Regulatory Framework For SaMD

Use-Related Risk Analysis For Combination Products

5 Focus Areas For Medtech Business Success In 2024

Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices And Biopharma

RESOURCES

Sterilization

Pharma+ Tubing Retainers

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