As medical devices are increasingly connected to central systems within hospitals, numerous cybersecurity challenges have emerged for medtech manufacturers. For example, networked medical devices need to be secured from risks, including hacking and malware. The FDA, as a part of its Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, recommends that manufacturers describe how their device addresses cyber security.
Download this whitepaper to learn how Battelle develops a security baseline that all devices are designed and validated against.
- Learn what is involved in a security baseline assessment
- Understand the National Institute of Standards and Technology 800-53 standards