CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001

Managing Cybersecurity Vulnerabilities

Throughout the Product Lifecycle

Certified ISO 27001

We help Medtech manufacturers address cybersecurity throughout the product lifecycle, including during the design, development, deployment, and maintenance of the device.

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.




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.

Security Mitigation for Legacy Medical Devices

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 They were built using outdated or insecure software, hardware, and protocols that no longer support patches or updates leaving them susceptible to cyber-attacks.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.



Security-by-design for medical devices


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:

  • Monitoring of and mitigations for the OWASP top ten security risks
  • Generation/monitoring of software dependencies in the Software Bill of Materials (SBOM)
  • Implementation of HIPAA password guidelines
  • Protecting and isolating user credentials
  • Protecting and isolating Personal Identifiable Information (PII)


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.

Don't let cybersecurity vulnerabilities threaten the safety and marketability of your medical devices.

Contact us today to learn how we can assist your team in assessing product risk and in developing and executing a mitigation plan.

Why Is Cybersecurity for Medical Devices Important?

As medical devices become more interconnected and reliant on the internet, they become more vulnerable to cyber threats. These risks range from unauthorized access and control of medical devices to the theft of sensitive patient data. The implications are profound, affecting not just the functionality of the devices but also potentially leading to critical health risks for patients.

Understanding the Risks:

Data Breach: Unauthorized access to confidential patient data can lead to privacy violations and identity theft.

Device Tampering: Cyberattacks can alter the functioning of a device, risking patient health.

Service Disruption: Cyber threats can cause system failures, interrupting essential medical care.

Mitigating the Risks: What Can Manufacturers Do?

The FDA urges manufacturers to monitor and assess cybersecurity vulnerability risks, and to be proactive about disclosing vulnerabilities and solutions to address them.

Conduct a Vulnerability Assessment: The assessment evaluates if the system is susceptible to any known vulnerabilities, assigns severity levels to those vulnerabilities, and recommends remediation or mitigation.

Implement Robust Encryption: Ensuring data transmitted to and from the device is encrypted can protect against interception and misuse.

Regular Software Updates and Patches: Keeping software up to date is crucial to protect against known vulnerabilities.

Secure Device Authentication: Employing strong authentication mechanisms can prevent unauthorized device access.

Develop a Rapid Response Plan:A clear, swift response strategy for potential breaches is essential for minimizing risks.