Empowering Medical Innovation with Secure, Compliant Solutions

Lynx helps medical device manufacturers secure their devices, ensure compliance with stringent regulations, and maintain reliability throughout the product lifecycle. With industry-leading expertise and proven results, we enable you to deliver life-saving technologies confidently. Seize the Edge with Lynx’s industry-leading solutions for FDA cybersecurity compliance and medical device cybersecurity. With 82% of healthcare IoT devices being vulnerable, Lynx ensures your systems are secure and ready for certification.

Challenges Facing Medical Device Manufacturers

The medical device industry operates under relentless pressure to innovate while meeting strict regulatory requirements. Lynx understands these challenges and is here to help you overcome them.

Cybersecurity Threats: IoT-connected devices are prime targets for cyberattacks, risking patient data and functionality.
Regulatory Complexity: Navigating FDA, IEC 62304, and ISO standards can slow time-to-market and strain resources.
Lifecycle Maintenance: Devices require long-term support to remain secure and compliant in a rapidly evolving landscape.
Innovation Pressure: Accelerating development cycles without compromising safety or compliance is a persistent challenge.

82% of Healthcare IoT Devices are Vulnerable

A recent study found that the majority of IoT-enabled healthcare devices have known vulnerabilities, highlighting the urgent need for proactive security measures. (Source: Cybersecurity News)

$6.5 Million Average Cost of a Healthcare Data Breach

The financial and reputational impact of breaches underscores the critical importance of robust cybersecurity. (Source: IBM Security)

12-18 Months Average Compliance Timeline

Navigating FDA and IEC 62304 requirements adds significant time to the development cycle. (Source: Medical Device Online)

70% of Medical Devices Face End-of-Life Risks

Lack of long-term maintenance strategies leaves devices vulnerable and non-compliant. (Source: Industry Reports)

How Lynx Helps You Secure and Innovate

Lynx delivers solutions that simplify compliance, secure devices, and ensure long-term lifecycle support. Whether managing IoT security or maintaining embedded systems for 10+ years, Lynx enables you to stay ahead of the industry’s toughest challenges.

Secure IoT-enabled devices against emerging threats.
Streamline FDA and IEC 62304 compliance processes.
Save up to 60% on maintenance costs with long-term BSP support.
Reduce risk by 95% with proactive vulnerability management.

Stay Compliant with Industry Standards

Lynx provides the expertise and tools to help you meet key medical device regulations seamlessly.

FDA Cybersecurity Compliance

Achieve premarket and postmarket compliance with guidance tailored to your devices.

IEC 62304 Certification

Streamline software lifecycle processes with expert support.

NIST 8259 Compliance

Enhance IoT device security with guidelines and tools to protect patient data.

Global Standards Support

Navigate ISO/IEC standards with confidence using Lynx’s proven methodologies.

Tailored Solutions for Medical Programs

VigiShield

Secure boot, encryption, and OTA updates to protect medical devices from cyber threats.

Vigiles

SBOM management and vulnerability tracking for lifecycle compliance.

Long-Term Support (LTOS)

10+ years of kernel and BSP maintenance for continuous security and functionality.

Software Application Development

Accelerate innovation with tailored software solutions built for compliance.

Long-Term Maintenance for imaging devices

Securing Autoclaves for Compliance

Lynx implemented secure bootloader signing and kernel hardening for a leading autoclave manufacturer, ensuring FDA compliance and protecting patient safety.

Long-Term Maintenance for Imaging Devices

An i.MX6-based imaging platform achieved 60% cost savings with Lynx’s lifecycle support services, ensuring 10+ years of compliance and security.

Explore Our Security Solutions