Visit Medbio at DeviceTalks Boston 2026 to explore scalable manufacturing solutions supporting next-generation robot-assisted surgical systems, precision molding, automation, assembly, and ...

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering ...

Despite huge investment in intelligent tools, results are patchy. Ownership is unclear, integration is limited, and teams ...

Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu ...

High-purity PFA tubing is engineered to meet the rigorous demands of precision fluid handling applications where reliability, cleanliness, and performance are critical. Manufactured from PFA ...

Raising funds in the medical device industry is always challenging. Doing so as a startup can be even more so. And U.S. medical device companies seeking funding this year will find that innovative ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

A failed Bowie-Dick test signals more than a minor setback; it’s a warning that your sterilizer may not be achieving the conditions required for effective steam sterilization. These failures can lead ...

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. We've mastered ISO 13485, understood CFR 820, and navigated EU MDR ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...