Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

While Mexicos health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has ...

An informational overview examining category context, publicly available product disclosures, and what consumers often ...

As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness ...

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

Compliance is one of the most persistent bottlenecks in regulated software development, often requiring weeks or months of manual documentation after products are built. In this episode of DEMO, Keith ...

Machine design engineers working in the medical device field might draw inspiration from AuraWell’s iterative, ...

Covestro displayed new medical devices using advanced polycarbonate materials for home healthcare and military applications.

At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022 ...

Global Medical Virtual Assistant Market size is expected to be worth around US$ 5.9 billion by 2033 from US$ 0.5 billion in 2023.

Keeping up with the medical device world can feel like a lot. There are new regulations, cool tech popping up, and just generally a lot to track. That’s why signing up for the right medical device ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...