Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen.

2. ISO 14971 – Medical Device Risk Management ISO 14971 is the standard for risk management in medical device development, including software. It requires comprehensive risk identification ...

Introducing Building Code for Medical Device Software Security, a set of guidelines to help companies establish a secure baseline for software develop ...

Key Takeaways Ensuring technical quality and safety is critical in medical device software development, requiring a documented, repeatable process and extensive testing.

Sagentia has developed a free whitepaper Medical devices: the shift from embedded to connected to help decision-makers develop a 'risk compass' to navigate this environment.

For example, IEC 62304 Medical Device Software — Software Life Cycle Processes is an international standard that provides a framework for developing and maintaining SaMD and software within ...

“Enhancing medical devices with software is also an easy way to add features and improve the way the system works.” But as more medical device companies embrace software, more have to get to grips ...

Today the IEEE Cybersecurity Initiative released “Building Code for Medical Device Software Security” to help establish secure code development for software that runs in a wide range of ...

The Old FDA Process Medical devices, medical apps and software as a medical device (SaMD) are all products subject to FDA, FTC and HIPAA regulations. Compliance with FDA regulations has been ...