medical device certification Articles
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4 factors that make a nasal aspirator safe
Do you remember the moment when you found that you have to clear your baby’s nose? You probably thought it was a joke and you didn’t want to believe it. “A nasal aspirator? What else will they come up with… Do I really need it? Is that even safe?!” Most parents share your doubts at first. However, these uncertainties disappear once you find out how much relief a ...
By Nosiboo
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Yaguo launches an Innovative Medical Device
At the beginning of Chinese New Year, Beijing Yaguo Technology Co., Ltd.'s innovative medical device "Respiratory Power" respiratory neuromuscular stimulator was officially launched. "Respiratory power" has been established in 2015 as a core innovative product of Yaguo, Through 4 years of continuously efforts, after research, demonstration, design, development, and clinical registration it has ...
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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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BlueLavage – Proven concept with innovative ideas
Lower costs, more security, easier handling and optimal CO 2 balance: With the BlueLavage® rinsing and suction system, UTK Solution GmbH has succeeded in adapting a proven surgical technology to modern clinical processes. The heart of the innovation is the reusable charging and energy unit, which completely avoids electronic waste and whose optimized energy transmission ensures smoother and ...
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Newly Released FDA Guidelines for Sepsis Detection & what it Means for Hospitals
Executive Brief On September 28, 2022, the FDA released Clinical Decision Support, Guidance for Industry and Food and Drug Administration Staff. This guidance is long overdue, and with it comes the elimination of any protections for EHRs, or any other vendors, to pretend it’s OK to sell or deploy solutions for patient monitoring and care for life-threatening conditions like sepsis, that ...
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