The De Novo pathway by the US FDA, is a risk-based classification process to classify novel medical devices.
FDA is collaborating with CDC and HICPAC to seek inputs to improve the efficacy and safety of reprocessed devices.
“The advance of technology is based on making it fit in so that you don’t really even notice it...”
More than 190,000 distinct medical devices are regulated by the FDA!
The wearable ECG monitor band typically has 3 electrodes and a user interface with a button to switch on the system.
Behind every innovation, there are years of hard work, passion, and perseverance.
Rita, a nurse at PCN Health Care Hospital logged into her system on a Monday morning to retrieve a patient’s ...
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What is continuous improvement and how can we achieve it?