The human kidney is a masterclass in biological engineering. Responsible for filtering approximately 50 gallons of blood ...

FHIR (Fast Healthcare Interoperability Resources) is an open standard designed to streamline data sharing within national ...

This silent crisis has dire consequences. Patients face delays, errors increase and the entire system suffers. This cannot ...

How does combining AI with Lean Management significantly improve efficiency in MedTech engineering? AI, much like IDEs or CAD tools before it, is becoming an essential enabler in reducing friction ...

Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device ...

In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters. 1 Medical device manufacturers often struggle to keep up with complaint investigations ...

Annex IV (EC Declaration of Conformity – Full Quality Assurance System) of the IVDD (98/79/EC) is all about delineating specific regulatory requirement for devices falling under List A of Annex II.

Artificial intelligence (AI) has become a commonplace reality as technology advances. Healthcare is one sector that is quickly changing on a big scale. From the issuance of electronic healthcare cards ...

Fueled by a near-constant stream of advancements in technologies and treatments, increased healthcare spending and a strong economy, the medical device industry is growing dramatically with no end in ...

As has been widely noted, the COVID-19 pandemic has prompted countless people to rely on telehealth and virtual monitoring for their healthcare needs. This dramatic pivot is catalyzing a demand for ...

Fabricio Pamplona, Ph.D., is the founder of Mind the Graph, an online platform that offers thousands of accurate medical illustrations that users can download. Pamplona has a background in ...

In an election year, healthcare tends to dominate the conversation—talk of insurance coverage, pharmaceutical prices and out-of-pocket spending will likely ramp up tenfold now that we’ve turned the ...