Securing Connected Medical Devices for FDA Submissions

The benefits and challenges of the Internet of Things (IoT) are especially evident in healthcare, thanks to increases in the volume and use of medical devices. Network-connected devices have greatly improved patient care by helping healthcare providers monitor vital signs, regulate medication dosages, improve diagnostics, and ultimately improve patient outcomes while lowering costs. 

This white paper investigates the security and regulatory landscape of medical devices, especially as it relates to the U.S. Food and Drug Administration (FDA). It provides best practices for medical device manufacturers and healthcare delivery organizations looking to achieve and maintain FDA regulatory compliance.

Download the paper to learn about:  

• Medical device security, safety, and regulatory risks
• FDA clearance and approval processes
• FDA premarket and postmarket guidance
• Challenges of FDA cyber security compliance
• Best practices for meeting FDA guidelines