Iso 13485 2016 Upgrade Certification Articles & Analysis: Older
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Patients who need medical treatment often fear being exposed to harmful germs and unsanitary instruments. Just the thought of a healthcare provider using an unsterilized surgical device or needle is enough to make people feel queasy. As a result, patients find it reassuring to watch a clinician remove healthcare devices from sterile packaging before starting a procedure. Sterile packaging ...
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 ...
The term sepsis describes the body's extreme response to infection. When a person suffers from sepsis, his or her immune system has been triggered in response to an infection, which causes inflammation and damages tissues in the body. Symptoms of Sepsis The symptoms of sepsis may include: Fever (102 degrees Fahrenheit or higher) Chills Rapid breathing (above 20 breaths per minute) or ...
The medical device industry is worth hundreds of billions of dollars, but companies who take their eye off the ongoing need for quality management could find themselves under an unwelcome federal compliance spotlight. According to a recent U.S. Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities ...
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