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 ...

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

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

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 ...

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

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 ...

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 ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...

In 2017, our Boston Scientific leadership team found ourselves faced with a dilemma. Poring over our annual employee survey results, we were taken aback to learn — much to our chagrin — that not all ...

FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors ...