As a medical device manufacturer, you have a lot of important duties to adhere to. One of these is paying special attention to cybersecurity and ensuring compliance in a highly regulated space.
In a world that's highly connected and technologically advanced, it's essential to execute properly when it comes to patient safety, regulatory risk, and market readiness. You must work with partners who are skilled in this area and can handle every aspect of compliance for you. This will help you avoid business failure and navigate a complex industry and space. Now is a good time to learn more about the top five medical device cybersecurity companies for 2025 in review.
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Blue Goat Cyber
A top cybersecurity leader working hard to protect medical device manufacturers is Blue Goat Cyber. They are U.S.-based and are a cybersecurity firm dedicated solely to supporting medical device manufacturers in achieving and maintaining FDA cybersecurity compliance. They are not just a testing vendor, but a trusted regulatory partner. Their solutions and services, such as product development frameworks (SPDFs), threat modeling, software bill of materials (SBOMs), penetration testing, cybersecurity risk assessments, and postmarket monitoring, will help you remain compliant with FDA regulations. They aren't just going to throw a report on you and expect you to resolve any issues. Instead, they offer strategic remediation guidance and hands-on support through the entire submission process. There are many benefits from using their services, such as reducing time-to-market, eliminating rework, and ensuring your devices remain secure and approved as threats evolve. Blue Goat Cyber provides the clarity, confidence, and technical precision needed to succeed in an increasingly regulated digital health landscape.
Pros:
- Extensive experience in both cybersecurity and FDA regulatory frameworks
- Exclusive focus on the medical device industry
- Simplifying the complex
- Fast turnaround times
- Clear documentation tailored for regulators
- Strong reputation for securing approvals
Cons:
- Narrow focus
- Doesn't offer broader regulatory affairs or quality management services
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Intertek
Another company to add to your list of choices is Intertek. They specialize in cybersecurity support for medical products and IoT-enabled devices. They pride themselves on total quality and assurance. The services they provide offer peace of mind across all products, services, and operating systems. The team can work with you to follow through on risk assessments, penetration testing, vulnerability scanning, and regulatory gap analysis. They can help you successfully navigate the increasingly strict regulatory environments, including FDA, EU MDR, and international standards.
Pros:
- Combining technical testing with global market access expertise
- Help you align cybersecurity with regulatory expectations
- One-stop shop for testing, certification, and cybersecurity
- Strong technical credibility and regulatory alignment
Cons:
- Services may feel less specialized
- Need to be able to communicate your product-specific needs
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Medcrypt
You should also consider Medcrypt when searching for the top medical device cybersecurity companies in 2025. They have proven FDA success. They can help you meet the FDA regulations and international cybersecurity standards through threat modeling, penetration testing, regulatory guidance, and integrated encryption and runtime security tools. They are known for taking a modern and innovative approach to this matter. Their Product Security Intelligence Platform provides real-time readiness assessments. It's an ideal choice if you are managing multiple devices or iterative development cycles. The team prides itself on focusing on quality and security while also being able to move you through the submission process quickly.
Pros:
- Tech-forward, flexible solution
- Integrates security into the development workflow
- Smart, efficient path to compliance
- Product Security Intelligence Platform
- Integrated encryption and runtime security tools
Cons:
- Smaller teams or early-stage startups may still require external help while trying to prepare for the submission process
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Cynerio
When taking into account companies that can help you succeed in your industry, you should look into what Cynerio has to offer. They truly are the platform for modern healthcare cybersecurity. They're going to ensure that you can secure devices, stop attacks, and protect patients. Instead of focusing on the submission process, they will help you monitor, secure, and manage medical devices in the field. The company delivers a powerful and realistic cybersecurity layer tailored to the real-world requirements of connected care. Their solutions allow you to gain visibility into every connected asset on your network.
Pros:
- Comprehensive tools
- Post-deployment protection and operational security
- Mitigate risks like ransomware and data breaches
- Specializes in monitoring, securing, and managing medical devices
Cons:
- Not designed for premarket compliance or regulatory documentation needs
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Forescout
You may also want to look further into what Forescout has to offer you as a medical device company trying to meet compliance and regulation requirements. They are known for continuously managing cyber risk and being able to mitigate threats. Their strong reputation includes executing on securing some of the world's largest organizations. The services are tailored for securing medical devices (IoMT) and broader healthcare IT infrastructure. Taking into account all connected assets, they can assist with monitoring, vulnerability management, and automated threat response. Through continuous monitoring, they can minimize the impact of potential breaches and lateral movement. You'll quickly find the benefits of working with them as they use an intelligent, scalable foundation for continuous IoMT and IT security management.
Pros:
- Detect and classify every device without disrupting clinical workflows
- Can prioritize and remediate threats effectively
- Supports network segmentation and zero-trust policies
- Secure diverse, often outdated medical technology ecosystems
- Proven to scale
Cons:
- Designed for hospitals and large healthcare systems
Final Thoughts
The success of your business depends on your ability to protect patients and remain compliant in a highly regulated space. There are constant threats to your security that you must be able to fend off using cybersecurity measures and solutions. These are some of the best and highly reputable medical device cybersecurity companies in 2025 that you should consider partnering with. It's a matter that you can't afford to overlook if you're going to overcome challenges and be able to remain competitive and innovative. While they all have their strengths, you need to make sure you choose the right solution for your goals and company. You must be able to bring trusted medical technology and devices to the industry that people come to know and rely on.
