Cybersecurity for Medical Devices
Cybersecurity is no longer optional for connected medical devices—it’s a critical requirement. A single vulnerability can lead to data breaches, regulatory setbacks, or compromised patient safety.
We specialize in building secure-by-design software architectures that protect sensitive data, ensure system integrity, and meet evolving cybersecurity standards, including FDA premarket and postmarket guidance.
Ready to accelerate your medical device development? Let's talk about how our expertise can reduce risk and streamline development.
Managing Cybersecurity Vulnerabilities Throughout the Device Lifecycle
In an era where technology and healthcare converge, the advancement of medical devices has transformed patient care, offering unprecedented opportunities for monitoring, diagnosis, and treatment. However, this connectivity brings with it a significant challenge – cybersecurity threats, which pose a real risk not only to the integrity of medical devices but also to patient safety and data privacy.
Our experts address the unique challenges of MedTech cybersecurity—secure data transmission, device authentication, encryption, threat modeling, and SBOM (Software Bill of Materials) compliance. By integrating security into every phase of development, we help you launch connected devices with confidence, knowing they’re built to withstand real-world threats and regulatory scrutiny.
For medical device software, compliance with regulatory standards such as the FDA’s Pre-Market and Post-Market Cybersecurity guidelines, HIPAA in the U.S., and the GDPR in the EU, is non-negotiable.
At Syncro Medical, we address cybersecurity throughout the software product development cycle. Our proactive approach ensures that security considerations guide the design decisions, architecture selection, and development practices. This approach not only helps in mitigating risks but also fosters trust among users and stakeholders.
One of the biggest cybersecurity challenges for Medtech manufacturers comes in defending older legacy medical devices against new cyber threats. Many of these devices, in operation today, were not conceived with cybersecurity in mind. They were built using outdated or insecure software, hardware, and protocols that no longer support patches or updates leaving them susceptible to cyber-attacks.
Syncro Medical is available to help our clients identify and address vulnerabilities in their legacy devices to ensure a strong cybersecurity stance for their products.
CLIENT CASE STUDY
Managing Cybersecurity Risk for a Cloud-based Patient Management Platform
Our client is a medical technology company that develops products to improve the quality of life for patients with neurohealth disorders. They rely on Syncro Medical to design and implement cybersecurity measures for their cloud-based patient data management platform including:
- Generation/monitoring of software dependencies in the Software Bill of Materials (SBOM)
- Monitoring of and mitigations for the OWASP top ten security risks
- Implementation of HIPAA password guidelines
- Protecting and isolating user credentials
- Protecting and isolating Personal Identifiable Information (PII)
CLIENT CASE STUDY
Mitigating Cybersecurity Vulnerabilities in Legacy Medical Devices
A global medical technology company engaged Syncro Medical to accelerate software fixes of known security vulnerabilities for a legacy market-leading product in their diagnostics portfolio.
Our client faced a pivotal challenge when results of a software vulnerabilities assessment identified five priority categories and they did not have sufficient internal software development resources available to address the problem.
Syncro Medical quickly mobilized by creating and then executing a plan to mitigate the complex array of security vulnerabilities. As a result, this client was able to address the problem while keeping their internal resources focused on other critical projects and priorities.
DEVELOPMENT EXPERTISE
We support our clients at every stage of the medical device software design and development process
Learn more about how we help our clients accelerate software R&D for their market-leading devices.