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Medical Device Management Articles & Analysis

5 articles found

SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management

SmartFreezer®: Meeting the Medical Device Directive for Safe Sample Management

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 ...

ByFroilabo - Techcomp Group


A Quick Overview of ISO 13485 Requirements for Medical Device Companies

A Quick Overview of ISO 13485 Requirements for Medical Device Companies

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. ...

ByQualityze Inc


Miamitech Startup Spotlight: Dalent Aims to Improve Sinus Surgery Experience, Outcome and Cost

Miamitech Startup Spotlight: Dalent Aims to Improve Sinus Surgery Experience, Outcome and Cost

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. ...

ByDalent Medical


The Importance of Quality Management in the Medical Device Industry

The Importance of Quality Management in the Medical Device Industry

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


QMS Expert vs QMS Expert...alias - Today Everybody is an Internet Certified QMS Expert

QMS Expert vs QMS Expert...alias - Today Everybody is an Internet Certified QMS Expert

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. ...

ByqmsWrapper

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