We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of ...

Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on ...

For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date.

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.

Integrating a sharpened metal cannula with overmolded plastic components requires solving complex intersections of material science, precision engineering, and high-volume production. Securing ...

Bridging the gap between a successful point-of-care (POC) assay prototype and full-scale commercialization requires early strategic alignment across design, chemistry, and high-volume production.

Developing next-generation digital droplet technologies demands exceptional manufacturing precision, rapid design refinement, and scalable production methods. This customer success story highlights ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...

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 ...