R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Cybersecurity

My recent work has involved providing regulatory assistance to software medical devices. One thing I have been learning about is how security and privacy is handled with these types of products. Often times I have experienced clients grouping regulatory affairs with privacy and security. Project teams have looked to the regulatory engineers for guidance on how to handle privacy and security of patient data used within the software. This was a new area of focus for me. In my research on privacy and security I looked a lot to internal experts on these to subjects, in addition the FDA has issued a draft guidance titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Mobile Medical Applications: Innovation vs. Regulation

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.

Mobile Medical Applications: Wellness Apps

After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.

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