A recent survey conducted with BioPhorum members revealed that the most critical aspect of digital healthcare for drug delivery devices. Lets take a closer look.

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

Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you ...

Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and ...

Cut the clutter, chaos, and compliance complications. Move to a modern compliance platform that your team will actually use.

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 ...