No matter what business you're in, paperwork and digital documents tend to pile up. Without a good document control process, you may have problems, warns Qualio. You might not find the documents you ...

If you want to learn about usability, then reading a standards document may not be the easiest starting point. However, standards that address usability for medical devices do exist. Companies must be ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...