Deploy Life-Saving Devices
Build better 'intelligent' machine-to-machine systems
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.
To shorten certification time and increase time-to-market, many medical organizations reuse or leverage external libraries, and code that is “proven in use” – to shorten their development time and reduce cost. However, this typical software of unknown pedigree (SOUP) must still be considered in the overall evaluation of the safety and effectiveness of the device.
GrammaTech CodeSonar's medical solution supports this process by providing a deeper, more thorough analysis of the complete system using static analysis of both written (or re-used) source as well as 3rd-party binaries, unlocking hidden defects, speeding up the 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 the liability.
CodeSonar helps you comply with medical coding standards:
- IEC 61508
- IEC 62304
- FDA Validation Guidance
- Mitre's CWE
- Build Security In (BSI)
- U.S. CERT
A New Frontier for Medical Devices
The medical device market is evolving very quickly and in many dimensions – new technologies now connect hospitals and clinics with remote patients and devices, wearable devices now proliferate the marketplace, more robotics are being used for high-precision procedures, and data/diagnostics are being compiled through big data, making the industry more vulnerable to hackers than ever before.
Organizations that invest upfront and understand the complexities of the evolving medical market can put together a winning strategy to succeed in the medical device marketplace.
New Patient Demands
Home health care and medical wearables are increasing exponentially, increasing safety, security, and privacy concerns.Learn more
New remote medical devices require new, faster technologies using multicore and multithreaded code.Learn more
Increased connectivity to the internet and to the cloud is causing new security weaknesses in medical devices.Learn more
Use of Third-Party Software
Third-party software must be inspected carefully before use. You can use CodeSonar to to find defects and security vulnerabilities in these third-party binaries.
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Increased Network Connectivity
For new medical environments that are uniquely both security-critical and safety-critical, CodeSonar will help you mitigate security risks.
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Join other organizations who rely on GrammaTech for assuring safety and security in medical devices:
The Role of Static Analysis in Management of Cybersecurity in Medical Devices
Recognizing the need for more robust security in medical devices, the FDA issued its guidance on managing cybersecurity in 2014. But the growth of wireless, networked, and internet-connected devices means that medical devices are more at risk than ever before. The issues of patient safety and privacy also put medical devices in a category of their own.
This paper describes how static analysis plays a key role in risk management of medical device software development.
Making Safety-Critical Software Development Affordable with Static Analysis
Safety-critical software has hit the "affordability" wall due to increasing complexity and growing reliance on software to perform mission-critical functions. Although software developer productivity on safety-critical systems hasn't really changed over time, with the growing reliance on software, the code size for safety-critical software has skyrocketed.
This paper describes how to use static analysis tools to tackle the growing software affordability concern.