Newsletter | January 23, 2025

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

FEATURED EDITORIAL

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

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 This article shares the 13 key takeaways, including differences from the draft guidance.

5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies

2025 will be the year for pharmaceutical companies to revisit their drug delivery device strategies or risk being left behind. Here are the five reasons why.

INDUSTRY INSIGHTS

Reducing Human Error In Healthcare Operations

Implementing an IoT platform powered by RFID enables clinicians to effectively use medical equipment and reduce human error in healthcare processes to ensure higher quality of care.

Piezoelectric Disc Pumps: Complete Fluid Control

The Lee Company is wholly dedicated to high-precision fluid control. We offer a wide range of solutions, all engineered to deliver the highest levels of reliability and performance.

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.

The Benefits of Aqueous Critical Cleaning In Manufacturing

The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.

5 Common Medical Injection Molding Business Mistakes

A full-service medical injection molding company should focus on what is necessary to help customers be highly successful by keeping them at the forefront of technology and in front of their competition.

ARTICLES YOU MAY HAVE MISSED

9 Strategies To Overcome Challenges In The EU Medical Device Market

5 Trends In Digital Therapeutics For 2025

How To Prevent Device Misuse Through Formative Studies

The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025

How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?

RESOURCES

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