IEC60601-1 to IEC60601-1-4 provides details guidelines for the technical standard for the safety and effectiveness of medical electrical equipment design. The IEC60601 fourth edition is a mandatory adoption by Europe and the US FDA and Health Canada. The goal is to provide medical devices that are safe and effective.
Functional Safety IEC61508 standard for electronics will play a key role in medical devices in the upcoming years. Working with certifying bodies, Xilinx’s tool and safety design methodology has achieved IEC61508 certificate.
To aid customers in designing in safe and effective medical products with Xilinx devices, a comprehensive functional safety package is available. The solution package includes tool suite, IP and documentations to reduce design risk and help customers make safer and medical devices for everyone.
Healthcare is one of the major industries that have been hit in the last few years by cyber-attacks. No standardized mix of System Security Methodologies & Policies exist worldwide and in the US within Healthcare to address the challenges. In the last few years, the US FDA has published cybersecurity management guidelines to medical equipment OEMs, both for post-market management and for pre-market submissions.
The importance of safeguarding medical equipment and healthcare networks from cyber attacks as well as cloning has become of paramount importance.
Security must be considered throughout the entire product lifecycle to maximize the protection of a system.
Xilinx and their customers have a shared responsibility to ensure the security of a system. It is also important to recognize that no system is completely immune to attack - with enough time, energy, resources and money, any system can be compromised. Security is all about managing risk, and how much investment a customer wants to make to manage that risk.
Xilinx employs world-class best practices to establish the trustworthiness of its Silicon, Software and Development Tools. An array of countermeasures are integrated into Silicon which aid in protecting against a myriad of attack vectors. The secure boot, or configuration, of our products employ a Hardware Root of Trust with Authenticity, Confidentiality, and Integrity built in.
The device, after booting securely, must maintain the security that has been established. Run-time protections are a shared responsibility between Xilinx, the customer, and the rich Xilinx ecosystem.
The Xilinx Alliance Program is an ecosystem of qualified IP providers, system integrators, and hardware suppliers that can accelerate your design productivity and get you to market faster. Alliance Program members are equipped to maximize the advantages of Xilinx Devices in developing market and domain specific solutions. To learn more about products from the Xilinx ecosystem, please visit this Alliance Products Search Results Page