The European Commissions simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry ...

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For years, Chile has occupied a strange position in Latin American medtech strategy. It was sophisticated, stable, commercially attractive, and comparatively easy to enter. For many medical device ...

Scaling biopsy device manufacturing from prototype to high-volume production presents complex engineering and operational hurdles. Slight variations in raw materials or individual components compound ...

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 ...

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 ...

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 ...

Ethylene oxide (EO) remains a foundational sterilization method for nearly half of all medical devices, particularly those with complex geometries or heat-sensitive materials. However, the industry is ...

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 ...

As we approach 2026, the digitization of the operating room is creating new and enlightening data sources asking to be better understood. The OR has evolved beyond just a sterile environment into a ...

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 ...