Newsletter | December 19, 2024

12.19.24 -- Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions

FEATURED EDITORIAL

The FDA's Guidance On PCCPs For AI-Enabled Device Software

In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

INDUSTRY INSIGHTS

Thin-Wall Polyester Heat Shrink Tubing In Medical Device Manufacturing

Nordson MEDICAL has developed a proprietary process to manufacture thin-wall heat shrink tubing from Polyester that exhibits extraordinary tensile strength, even with walls as thin as 0.00015”.

Cultural Audits: What Are They And Why Are They Essential?

The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

Precision Molding: Getting It Right The First Time

Precision injection molding ensures that the process can be consistently repeatable. Learn the critical steps that need to be considered for success with an injection molding project.

ARTICLES YOU MAY HAVE MISSED

A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests

How The EU AI Act Impacts Medical Device Manufacturers

Medtech: Capitalize On These 4 Trends To Thrive In 2025

Increasing Diversity In Medtech Innovation: A Personal And Professional Perspective

We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead

BULLETIN BOARD

Integrated Fluidic Subsystems

Learn about how expertise and precision manufacturing delivers reliable, efficient, and cost-effective solutions for your life science applications.

RESOURCES

Medical Grade Capacitors: MD Series

Steps For Proper Cleaning Validation

A Short Visual Guide To RFID Technology

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