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Medical Device Management Articles & Analysis
5 articles found
Medical devices are an essential component of healthcare, and they have significantly improved the quality of life for many patients worldwide. These devices may be categorised by their intended use and range from simple non-invasive items to fully implantable devices. The Medical Device Directive 93/42/EEC (MDD) is a regulation that sets out the essential requirements that medical devices must ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. ...
Agustin Arrieta, the co-founder and Chief Medical Officer of Dalent Medical, a Miami-based company developing innovative devices for ENTs, “has always been the type that’s looking to innovate and improve,” said his co-founder and COO, Peter Flores. ...
That’s why any medical device sold in the U.S. must have FDA approval. Additionally, meeting ISO standards gives your device credibility and is mandatory in some markets. ...
ByEtQ, LLC
The newbie QMS Managers Conundrum – 5 things to identify the right Expert? As a newly minted QMS manager in a medical device startup, I turned to the internet for what to do. ...
