medical device management Articles
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Miamitech Startup Spotlight: Dalent Aims to Improve Sinus Surgery Experience, Outcome and Cost
Originally appearing on RefreshMiami.com If you’ve ever had an awful sinus infection, you know how painful, and quite frankly, how much of a drag it is. But most of us don’t have Chronic Sinusitis, which consists of a sinus infection lasting longer than 3 months (despite treatment), according to the Mayo Clinic. That being said, 11.6% of the American population does, says the ...
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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. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
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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. Soon I had to realize that today everybody is an internet certified QMS expert. There was information galore, in fact so much information that trying to figure out what to even look at became the main problem. This ...
By qmsWrapper
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The Importance of Quality Management in the Medical Device Industry
As the world struggles to come up with a treatment for the COVID-19 virus, it’s important to remember all the amazing innovations taking place in the medical device and life sciences world: Implantable devices, like one that measures things like elevated filling pressure and weakened ventricular contraction, enabling physicians to detect risk of heart failure weeks in ...
By EtQ, LLC
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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 ...
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