Medical Device
Embracing the New Frontier for Medical Devices
Developing safe and effective medical devices requires a rigorous validation process that can be very time-consuming and costly without automation. Additionally, teams must comply with IEC 62304, transforming both their teams and development processes.
The FDA issued a final guidance document entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The document covers many aspects of device security and software security best practices including the role of software bill of materials (SBOMs) as a vehicle for risk management.
The FDA recommends that any premarket submissions include SBOM documentation for this software.
CodeSonar and CodeSentry support this process by providing a deeper, more thorough analysis of the complete system using static analysis of both written (or re-used) sources as well as 3rd-party binaries, unlocking hidden defects, speeding up the FDA certification process, and reducing your business liabilities through real-time visibility into your code quality.
Empower your teams to deliver the best intelligent medical devices on the market, without liability.
Accelerating Smarter, Secure Healthcare
The medical devices and systems used within our healthcare system and by the patients they serve are increasingly connected to facilitate information sharing and speed patient care. However, this comes with additional exposure which make these devices susceptible to cyber-attack. And older equipment historically insulated from attacks is now particularly vulnerable as legacy software becomes exposed to attackers. Remediation is difficult due to limited maintenance, limited understanding of potential underlying issues, and a lack of visibility into the software and components used.
CodeSecure solutions speed the development of safe and secure critical software by embracing shift-left practices, leading to better products for the health of patients and consumers.
Delivering Innovation with Confidence
Modern medical devices require connectivity, graphics, and a programming model that is understood by today’s engineers, but still complies with the stringent safety and security considerations set forth by the industry. The speed of innovation is influenced by embracing shared code and open-source software; however, these software contributions are often of unknown provenance and may not be developed to medical software standards.
CodeSecure solutions help medical device software developers more stringently fulfill the safety and security requirements associated with the device software they build.
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Fulfilling Premarket Approval Requirements
Medical Device Manufacturers (MDMs) are expected to conform to security guidance from the FDA as part of the regulatory submission process and attest to their capabilities and practices to meet cybersecurity mandates, particularly in the case of Software in Medical Devices (SiMDs).
CodeSecure solutions identify defects and compliance to coding standards during application development as well as support postproduction disclosure of vulnerabilities through the issuance of an SBOM that includes detailed component inventories and any corresponding open-source vulnerabilities.
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