Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

In medical device development, document approvals seem to always be a roadblock when you are the most pressed for time. How much time do you have to take to explain the change to an approver? What ...

Imagine a fire sweeping through a forest. It moves quickly, burns through almost everything in its path, produces immense destruction, and changes entire landscapes. It also clears out dead debris and ...

The most expensive decision a U.S. medical device company makes in Latin America is rarely the one its leadership team has on the agenda. It is not the choice of country. It is not the product ...

In micro medical manufacturing, a prototype that fits perfectly in the lab can still fail at production scale. When device performance depends on leak-tight seals, precise dosing, fluid flow, or ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...

A device is only as safe and effective as its weakest supplied input. That statement sounds obvious. Yet supplier quality failures remain among the most common root causes of medical device recalls, ...

New operators don’t fail because they’re careless. They fail because the instructions they’re given were never designed for real work on a modern shop floor. Paper binders go out of date. Text-heavy ...

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 ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

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 ...