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Adam T.
2018-12-08
Makes PDF files easy to manage!
It makes it easy for our employees to attain and manage pdf files on the go. It saves every time and is easily accessible.
There are times when it takes a few times to bring up the document. This may just be an internet issue on my end.
James C.
2018-11-06
Time saver!
I have used PDFfiller for several months now and love it. It is a great tool which makes it extremely easy for me to quickly and efficiently fill out PDFs and return them to the sender. Wether it be filling out forms or signing a contract, it has saved me many many hours in the long run - and is a pleasure to use!
There aren't really any cons to this plugin - it does exactly what it says it will do. However the user interface could be improved
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Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
Can software be a medical device?
Software with a medical purpose that operates on a general purpose computing platform, i.e., a computing platform that does not have a medical purpose, is considered Software as a Medical Device. Software as a Medical Device is capable of running on general purpose (nonmedical purpose) computing platforms.
How does a software qualify as a medical device?
Software with a medical purpose that operates on a general purpose computing platform, i.e., a computing platform that does not have a medical purpose, is considered Software as a Medical Device. Software as a Medical Device is capable of running on general purpose (nonmedical purpose) computing platforms.
What is a Class 1 medical device?
Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.
How do you classify a medical device FDA?
The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device's safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III.
What is medical software used for?
Medical software. Medical software is any software item or system used within a medical context, such as: standalone software used for diagnostic or therapeutic purposes; software embedded in a medical device (often referred to as “medical device software”);
What is medical hardware?
Medical hardware consists of any physical product that is used for medical purposes in patients, such as diagnosis, therapy or surgery. Revisit the Medical Hardware channel for a variety of breaking news, case studies and white papers related to medical hardware products.
Is software a medical device FDA?
According to Baku Patel, associate director for digital health, FDA Center for Devices and Radiological Health, Software as a Medical Device (Same) is defined as software intended to be used for more than one or more medical purposes that perform these purposes without being part of a hardware medical device.
What is a Class 1 medical device for the FDA?
Class 1. The US FDA defines Class I devices as devices which are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”
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