Medical Device Security and Safety

OVERVIEW

Before a medical device can be used in the clinical environment, the manufacturer must demonstrate that the device provides a medical benefit in routine clinical use, and also the device is hazard free. Demonstrating that a device is safe, secure and reliable systems is difficult. Certification and regulatory agencies routinely require full life-cycle traceability for the demonstration of fitness. Software traceability plays a critical role in demonstrating that a delivered software system satisfies all of its software design constraints and mitigates all identified hazards and threats. In this project we are developing Medical Device Development Tools that use safety and security reference models to help the manufacturer demonstrate that:

  • The device is free from risks that can lead to physical hazards.
  • Security threats are identified, and appropriate mitigation techniques are adopted.
  • Known domain specific vulnerabilities are identified and eliminated from the products.