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!
"For good ideas and true innovation, you need human interaction, conflict, argument, and debate."
Software has become an integral part of almost all facets of life including the healthcare and medical field.
The wearable ECG monitor band typically has 3 electrodes and a user interface with a button to switch on the system.
Applying for a CE Marking or have one already?
Breath Analyzers are one of the modern innovative devices that have emerged with the intent to improve healthcare.
Behind every innovation, there are years of hard work, passion, and perseverance.
Ever wondered if the product that you are using is safe?
Rita, a nurse at PCN Health Care Hospital logged into her system on a Monday morning to retrieve a patient’s ...
Globalization and international trade has drastically changed the face of the world.
Has managing documents always been a tedious and time consuming task for you?
What is continuous improvement and how can we achieve it?
Testing is to ascertain the working of the device as per its intended use, and to ensure its safety and effectiveness.
Product Development is unique, constantly changing, and very crucial.
A label is the display of information about a particular product on its packaging or on itself, which may be in written
Are you a Medical Device Manufacturer? An employee of a medical device company?