Newsletter | August 8, 2024

08.08.24 -- Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines

FEATURED EDITORIAL

Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines

This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.

INDUSTRY INSIGHTS

Key Considerations For Selecting A Medical Pump

When selecting a pump for medical devices, pressure and flow rate alone may not be sufficient. A thorough review of selection criteria is crucial to ensure the correct pump is chosen.

Avoiding The Pitfalls Of Rapid Scale In Medtech

For biotech leaders and R&D managers, anticipating and navigating challenges—from supply chain disruptions to quality control—are critical to sustaining growth and market competitiveness.

Extruded Medical Tubing: Process Parameters, Equipment Play Critical Role

Most medical tubing specifications comprise a drawing of a tube with the material, dimensions, and tolerances. However, parameters associated with the production of the tubing are also key.

ARTICLES YOU MAY HAVE MISSED

Data-Driven Trends In Predetermined Change Control Plans

System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks

8 Best Practices For Securing Investment In Diagnostics

The Growing U.S. Market For Endoscopic Gastrointestinal Devices

Medical Device Assembling And Packaging: Should You Outsource?

RESOURCES

Flexan Offers Rapid Extrusion

Steps For Proper Cleaning Validation

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