Software Security for Medical Devices

Ensure your medical devices and applications meet patient expectations and comply with regulations.

Trying to address customers’ cyber security needs and fulfill regulatory requirements can seem like an impossible task. To meet demands, you need to keep up with changing compliance requirements, test against a unique set of variables, and make sure software is shipped absent of flaws. With Synopsys tools and services, you can tackle compliance head-on, minimize risk, and be confident you’re shipping the highest-quality medical device software.

Medical Device Regulations and Compliance: FDA, IEEE, NTIA, MDISS, MDIC, AAMI, and NIST | Synopsys

Partner with a leader that understands medical device manufacturer needs

Navigating the medical device landscape can be complex, so it’s especially important to select a partner with medical device security knowledge and expertise. Synopsys is a key contributor in developing the secure design guidance documentation put out by leading agencies, consortiums, and working groups. Also, you can feel confident in partnering with us knowing that the world’s leading medical device manufacturers trust us to secure their most critical software devices and applications.

Let us help you navigate the complex medical device compliance landscape

The guidance and standards outlined by the FDA, IEEE, NTIA, MDISS, MDIC, AAMI, and NIST can be difficult to implement. Our medical device security services team of industry experts is poised to help you address:

  • IEC 62304
  • UL 2900-2-1
  • AAMI TIR57
  • FDA 510 (K)
  • FDA Premarket Cybersecurity Guidelines

From security program strategy and planning, to risk assessments and architecture reviews, to device- and protocol-specific security testing, our medical device security solutions combine tools and services tailored to your exact cyber security needs. 

Navigate the complex medical device compliance landscape | Synopsys
Software Bill of Materials | Synopsys

Find and fix security defects in proprietary and third-party code

Coverity static analysis helps you find and fix security defects in your proprietary code as it’s built. Uncover even more when you integrate Black Duck software composition analysis. Black Duck generates a comprehensive open source bill of materials (BOM), which you can easily export in SPDX format to help you build out a full software bill of materials (SBOM). Combining SAST and SCA allows you to track and manage security, quality, and license risks and meet anticipated pre-market guidance outlined by the FDA.

Address security issues before they ship

Medical devices use a diverse set of protocols, such as Bluetooth, HL7, and DICOM, that have the potential to carry zero-day vulnerabilities. With Defensics protocol fuzzing, you can proactively detect security defects during development and testing and avoid having to respond to breaches and device failures in the field.

Detect zero-day vulnerabilities & security defects | Synopsys

Tools, planning, and services for securing your medical devices

UL2900-201 compliance | Synopsys

Make sure your medical devices adhere to UL2900-2-1. Find out how. 

We understand medical devices’ unique security requirements and constraints