Medical device cybersecurity is now a legal requirement and not just good practice. With new FDA rules demanding threat modelling, SBOMs, and postmarket risk management, MedTech innovators need partners who can handle every aspect of compliance efficiently and reliably to avoid potential business failure.
Below are five firms doing high-quality work in the field. All deliver FDA‑aligned cybersecurity services, but each takes a slightly different approach.
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1. Blue Goat Cyber
Blue Goat Cyber is a veteran-owned cybersecurity firm dedicated exclusively to medical device manufacturers, offering full-service support across the product lifecycle. Their specialty lies in helping MedTech companies meet evolving FDA cybersecurity requirements with precision, speed, and confidence.
From premarket services like secure design consulting, threat modeling, SBOM creation, and penetration testing to postmarket risk management, Blue Goat Cyber handles it all. Their documentation is aligned with standards such as AAMI TIR57, ISO 14971, and IEC 62304, making it easy for manufacturers to prepare regulatory submissions that meet FDA expectations without costly rewrites or delays. Their approach includes submission-ready risk files, detailed test reports, and tailored remediation strategies.
One of their standout offerings is the “Assessment Evolution” model, a phased penetration testing process that includes retesting after mitigation. This reduces risk while strengthening the submission package. They also offer deficiency response support, helping clients quickly address FDA feedback to avoid prolonged review cycles.
Pros include highly focused MedTech expertise, fast turnaround times, clear documentation tailored for regulators, and a strong reputation for securing approvals. The only real trade-off is that Blue Goat Cyber doesn’t offer broader regulatory affairs or quality management services, but their narrow focus means deep technical clarity and fewer distractions.
For medical device teams looking to protect patients, accelerate time-to-market, and stay ahead of compliance challenges, Blue Goat Cyber delivers specialized expertise and peace of mind. Whether you’re launching your first device or managing postmarket obligations, they bring structure and security to an increasingly complex regulatory landscape.
2. Medcrypt
Medcrypt offers a modern, platform-driven approach to medical device cybersecurity, blending expert consulting with powerful self-service tools. Their core services include threat modeling, penetration testing, regulatory guidance, and integrated encryption and runtime security tools designed to meet FDA and international cybersecurity requirements.
A standout feature is their Product Security Intelligence Platform, which enables manufacturers to evaluate cybersecurity risks, generate remediation plans, and assess compliance readiness in real time. This scalable tool is ideal for MedTech teams managing multiple devices or iterative development cycles, as it reduces the dependency on manual consulting while maintaining regulatory alignment.
Medcrypt also supports SBOM generation, risk assessments, and documentation that aligns with FDA guidance, helping companies move faster through the regulatory process without sacrificing quality or security. But while their platform is powerful, smaller teams or early-stage startups may still require external help when preparing submission materials from scratch.
For manufacturers looking for a tech-forward, flexible solution that integrates security into the development workflow, Medcrypt offers a smart, efficient path to compliance.
3. Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides comprehensive consulting services for medical device manufacturers, covering both cybersecurity requirements and broader regulatory and quality system compliance. With decades of experience and a team that includes former FDA veterans, RCA helps companies navigate the complexities of both FDA and EU MDR submissions, offering support from concept through postmarket.
Their cybersecurity services include threat modeling, risk assessments, SBOM development, and documentation aligned with regulatory standards such as ISO 14971 and IEC 62304. What sets RCA apart is their integration of cybersecurity with quality systems, internal audits, and 510(k) or CE marking strategy, offering a one-stop solution for organizations managing multiple compliance fronts.
Some benefits of working with RCA include deep regulatory expertise, end-to-end service offerings, and the ability to coordinate cybersecurity within the larger framework of product approval and lifecycle management. Their extensive knowledge of submission processes can streamline approvals and reduce costly missteps.
The main consideration is that their cybersecurity work is often part of a broader compliance engagement, which may not be ideal for teams needing purely technical, stand-alone cybersecurity services. For MedTech companies looking for a comprehensive regulatory partner that includes cybersecurity as a key pillar, RCA delivers both strategic and operational value.
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4. Cynerio
Cynerio is a cybersecurity company focused on protecting connected medical devices (IoMT) and healthcare infrastructure within hospital and clinical environments. Rather than supporting device manufacturers through the FDA submission process, Cynerio specializes in helping healthcare providers monitor, secure, and manage medical devices once they are deployed in the field.
Their platform offers comprehensive tools for device discovery, risk profiling, network segmentation, and real-time threat detection, enabling hospitals to gain visibility into every connected asset on their network. Cynerio also helps mitigate risks like ransomware and data breaches through tailored remediation workflows and continuous monitoring.
However, it’s worth keeping in mind that Cynerio is not designed for premarket compliance or regulatory documentation needs; its value lies in post-deployment protection and operational security.
For healthcare systems and hospitals aiming to improve patient safety, reduce cyber risk, and meet compliance obligations at the point of care, Cynerio delivers a powerful and practical cybersecurity layer tailored to the real-world demands of connected care.
5. MedSec
MedSec offers a full-spectrum cybersecurity solution specifically built for the medical device industry, providing both technical services and strategic guidance across the device lifecycle. From early-stage product development through postmarket support, MedSec helps manufacturers secure their devices while maintaining compliance with evolving regulatory standards like FDA guidance, ISO 14971, and IEC 62304.
Their offerings include penetration testing, threat modeling, SBOM development, vulnerability assessments, and remediation planning. What sets MedSec apart is their focus on collaboration and education; they not only provide services but also train internal teams through the MedSec Academy, helping clients build long-term cybersecurity capabilities in-house.
While MedSec is a strong partner for technical cybersecurity, teams looking for full-service regulatory submission management may need to supplement with dedicated regulatory consultants.
For manufacturers seeking a trusted partner to build cybersecurity into their culture and processes, then MedSec delivers sustainable, standards-aligned protection and a foundation for long-term compliance success.
Choosing the right medical device cybersecurity partner depends on your product stage, internal capabilities, and compliance goals. Each company reviewed brings unique strengths to the table, but all share a commitment to patient safety and regulatory alignment–the key elements for bringing secure, trusted medical technology to market in 2025 and beyond.
