MEDIcept Insights

Medical Software: The mobile market and the FDA

It’s been predicted that mobile devices are poised to overtake traditional desktop computers as the channel of choice for accessing the Internet. With the variety of devices and their computing power increasing rapidly, growing numbers of patients and healthcare...

Premarket Submissions for Management of Cybersecurity in Medical Devices

The same data management technology used in consumer devices such as personal computers, smartphones, and tablets is increasingly being found in medical devices and is used to manage and transfer critical health information over wireless networks. To address the...

Securing Updated and Necessary Statutory Evaluations Timely Rule

In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force...