Newsletter | May 16, 2024

05.16.24 -- FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions

FEATURED EDITORIAL

FDA Warns Of Fraudulent, Unreliable Testing Data In Premarket Submissions

The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

INDUSTRY INSIGHTS

Bridging Human Expertise And AI: The Future Is Here

Discover how leveraging AI's capabilities while relying on human expertise can optimize human performance in the healthcare sector and pave the way for a more efficient, effective healthcare system.

Vascular Access And Sensor-Enabled Catheters: 5 Key Considerations

As we add sensors to more and more devices, procedure success, safety, and patient comfort all will benefit from smaller, faster, and more accurate sensors.

Testing And Selecting A Detergent Cleaning System

Testing and selecting an aqueous cleaning system involves a seven-step process. In this chapter of The Aqueous Cleaning Handbook, we walk through those steps to help you optimize your cleaning process.

Why Biological Indicators Survive A Validated Cycle

We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.

ARTICLES YOU MAY HAVE MISSED

Will Argentina Be The Next Medtech Clinical Trial Destination In Latin America?

Understanding The New MHRA Requirements For Medical Devices In Great Britain

A Holistic Approach To Your Medical Device’s Usability

Breaking Through The Blood–Brain Barrier: The Rise Of Focused Ultrasound

A Cost-Effective Approach To EU MDR Compliance

RESOURCES

Dispense Pumps

What Exactly Is Prototype Plus Molding?

Advanced Tubing Retainers: Pharma+

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