Safety and Security

Overview

Helping maintain the safety and security of Healthcare systems

Importance of Security

Healthcare has been hit in the last few years by cyberattacks. No standardized mix of system security methodologies and policies exists to address the challenges. In the last few years, the US FDA published cybersecurity management guidelines for medical equipment OEMs, both for post-market management and pre-market submissions. The importance of safeguarding medical equipment and healthcare networks from cyber-attacks, as well as cloning and IP protection, has become of paramount importance. Security must be considered throughout the entire product lifecycle to maximize the protection of a system.

Functional Safety

IEC60601-1 to IEC60601-1-4 provides guidelines for the safety and effectiveness of medical electrical equipment. The IEC60601 4th edition is a mandatory adoption by Europe and the US FDA and Health Canada. The Functional Safety IEC61508 standard for electronics will play a key role in medical devices in the upcoming years. 

Working with certifying bodies, the tool and safety design methodology from AMD has achieved IEC61508 certificate. To aid customers in designing safe and effective medical products with AMD devices, a comprehensive functional safety package is available. The solution package includes tool suite, IP, and documentation to reduce design risk and help customers make safe medical devices.