Medical Device Cybersecurity Services & Pen Testing

Compare medical device cybersecurity providers for SBOM management, threat modeling, penetration testing, and post‑market vulnerability monitoring. Find software platforms and specialist labs to support FDA cybersecurity submissions and emergency RTA fixes. Request quotes, compare capabilities, and select the right vendor fast.

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Compare Medical Device Cybersecurity Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

TÜV SÜD

TÜV SÜD is a leading testing, inspection, and certification company providing comprehensive medical device compliance services including importer/distributor compliance, MDR/IVDR consulting, and regulatory services. They offer both certification services and training programs for medical device manufacturers.

MedTech Europe serves as the European trade association for the medical technology industry, encompassing diagnostics, medical devices, and digital health. Their mission is to facilitate access to innovative medical technologies for more people while supporting healthcare systems in achieving sustainability. MedTech Europe actively engages with policymakers and stakeholders to promote policies that align with Europe's growing healthcare needs and expectations. They emphasize the value of medical technology through research, data, communications, industry events, and training. The association plays a crucial role in addressing key industry issues, including regulations like the EU MDR and IVDR, market access, and the advancement of digital health. They represent manufacturers and strive to foster an environment that supports innovation and responsible data use within the European Health Data Space. Founded in 2012, MedTech Europe is committed to shaping the future of healthcare by advocating for policies that enable the medical technology industry to meet evolving healthcare demands and improve patient outcomes.
Website: tuvsud.com
HQ: Brussels, Belgium
Languages: English, German
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Intertek

Intertek is a leading global provider of testing, inspection, certification, and auditing services for medical devices, pharmaceuticals, and consumer products. They offer comprehensive compliance and quality assurance services worldwide.

Intertek is a multinational assurance, inspection, product testing, and certification company. With a vast global network, they provide critical support to businesses across numerous industries, helping them navigate complex regulatory landscapes and ensure the quality and safety of their products. Their services are essential for importers and distributors seeking to comply with diverse market requirements and maintain consumer trust. Specializing in areas such as supply chain assurance, product conformity, and sustainability, Intertek empowers businesses to operate efficiently and responsibly. They offer tailored solutions that address specific industry challenges, from electronics and textiles to food and pharmaceuticals. By partnering with Intertek, companies can gain a competitive edge through enhanced product quality, reduced risk, and improved market access. For importers and distributors, Intertek's expertise is invaluable in verifying that goods meet all necessary legal and technical specifications before entering new markets. Their independent assessments and certifications provide credible evidence of compliance, facilitating smoother customs clearance and building confidence with consumers and regulatory bodies alike. This rigorous approach helps mitigate potential recalls, fines, and reputational damage.
Website: intertek.com
HQ: London, GB
Languages: English
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TÜV Rheinland

TÜV Rheinland is a leading global provider of technical services, offering testing, inspection, certification, and training. They specialize in ensuring product safety, regulatory compliance, and quality management systems.

TÜV Rheinland is a world-renowned leader in technical services, with a history spanning 150 years dedicated to making the world a safer place. With annual revenues exceeding 2.7 billion euros and a presence in over 50 countries, their approximately 27,000 employees provide expert services across a vast spectrum. Their core offerings include rigorous testing and assessment of technical systems and products, enabling innovation for businesses. TÜV Rheinland is instrumental in helping companies achieve certification for their management systems to international standards, ensuring quality and compliance. They also provide comprehensive training and qualification programs across numerous fields. Specializing in areas such as mobility, energy supply, and infrastructure, TÜV Rheinland delivers independent quality assurance. They are at the forefront of evaluating emergent technologies like green hydrogen, artificial intelligence, and autonomous driving, contributing to a safer and more sustainable future. Their expertise extends to regulatory compliance, including REACH regulations for chemical substances in the EU market, offering consultancy and testing services to manufacturers, distributors, and importers. TÜV Rheinland is committed to rigorous sustainability management, driving both ecological and economic security for their company and their clients. They offer solutions for businesses navigating complex regulations and seeking to enhance their operational safety and product quality.
Website: tuv.com
HQ: Cologne, DE
Languages: English, German
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UL Solutions

UL Solutions is a global safety science leader providing testing, certification, and advisory services for medical device EMC, hazardous locations, and more. They help ensure product safety, regulatory compliance, and market access worldwide.

UL Solutions is a premier global safety science leader dedicated to helping companies navigate complex regulatory landscapes and achieve market access. Specializing in areas critical to the medical device industry, they offer comprehensive Electromagnetic Compatibility (EMC) testing and certification services. This includes addressing susceptibility to and immunity from electromagnetic disturbances, crucial for medical technology advancements. Beyond EMC, UL Solutions provides extensive expertise in Hazardous Locations (HazLoc) compliance, offering advisory, auditing, testing, and certification verification. They help manufacturers obtain necessary credentials for global markets, including certifications like UL, C-UL, ATEX, IECEx, and others. Their global network of experts and state-of-the-art facilities ensures products meet local regulations and gain acceptance from EPCs, end-users, and code authorities. UL Solutions' broader service portfolio encompasses testing, certification, auditing, and advisory services across various domains. They leverage their deep expertise and global reach to accelerate product development, enhance security, and ensure compliance with international standards. By partnering with UL Solutions, companies can mitigate risks, demonstrate product quality and safety, and build trust in the global marketplace, ultimately achieving key business objectives and contributing to a safer, more secure, and sustainable world.
Website: ul.com
HQ: US
Languages: English
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Applus+ Laboratories

Applus+ Laboratories offers comprehensive testing, engineering, and certification services, specializing in EMC, wireless, and electrical safety for medical device manufacturers.

Applus+ Laboratories is a leading European company providing a wide array of testing, engineering, and certification services. With extensive experience and accredited laboratories, they support manufacturers in product development and validation across various industries, including medical device EMC testing. Their expertise spans structural testing, materials testing, non-destructive testing (NDT), fire testing, and EMC, wireless, and electrical safety testing. They are equipped to handle everything from component-level analysis to full-scale product validation, ensuring compliance with international and sector-specific standards. Applus+ Laboratories is committed to enhancing product safety, quality, and reliability through rigorous testing methodologies. Their services are designed to facilitate global market access and ensure products meet the demanding requirements of regulatory bodies and industry standards.
HQ: ES
Languages: English
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Medcrypt

Medical device cybersecurity platform offering SBOM and vulnerability management (Helm).

medical device cybersecurity: Get the Medcrypt advantage with our expert team of FDA and medical device experts to prepare for FDA cybersecurity readiness via regulatory strategy, penetration testing, threat modeling, process optimization, and more. Integrate and analyze your software supply chain to identify and mitigate vulnerabilities. Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.
Website: medcrypt.com
Provider Type: Both
Services: Penetration Testing (Manual/Hardware), SBOM Management (Software Tool), Threat Modeling & Risk Analysis
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: CycloneDX, SPDX
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Blue Goat Cyber

Medical device cybersecurity firm providing penetration testing services for FDA submissions.

medical device cybersecurity: ISO 14971 • FDA Guidance • UL 2900 • AAMI TIR57 • NIST 800-115 • IEC 62304 • ISO 13485 • AAMI TIR97 • ISO 27001 • IEC 81001-5-1 • IEC 62443-4-1 You’re building breakthrough medical technology to improve lives. But with FDA requirements, evolving cyber threats, and tight timelines, cybersecurity can feel overwhelming — and high stakes. We specialize in full-service cybersecurity for medical devices — so you can protect your patients, meet regulatory demands, and bring your device to market with confidence.
HQ: US
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, RTA Rescue (Submission Fix)
Submission Stage: Ready for 510(k)/MDR Submission, RTA Fix (FDA Refusal Response)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: SPDX, Other
RTA Rescue: Yes
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UL Solutions

Independent medical device cybersecurity testing and penetration testing services.

Website: ul.com
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis
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TÜV SÜD

Cybersecurity testing and assessment services for medical devices.

TÜV SÜD is a globally recognized leader in testing, inspection, and certification services. With a strong focus on safety, security, and sustainability, they provide comprehensive solutions across various industries. For the medical device sector, TÜV SÜD offers specialized expertise in cybersecurity, helping manufacturers navigate complex regulatory landscapes and ensure their devices are protected against evolving threats. Their services support product development, risk management, and market access, ensuring devices meet stringent international standards and maintain patient safety. Their commitment to excellence extends to rigorous testing and validation processes, ensuring that medical devices not only function as intended but also incorporate robust cybersecurity measures. This proactive approach helps mitigate risks associated with data breaches, unauthorized access, and device malfunction due to cyberattacks. By partnering with TÜV SÜD, medical device companies can enhance their product security, build trust with stakeholders, and achieve compliance with critical cybersecurity regulations.
Website: tuvsud.com
HQ: Germany
Provider Type: Service Firm
Services: Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
RTA Rescue: No
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Clearwater

Medical device security risk assessment and monitoring services.

medical device cybersecurity: Clearwater is the only company combining deep healthcare security and compliance expertise with MSSP capabilities, managed cloud services, consulting and assessments, and compliance software. We’re here to help organizations become more secure, compliant, and resilient. Clearwater knows healthcare, and we bring our two decades of experience to every client relationship. Our experts apply our unique, comprehensive approach to unite your cybersecurity and compliance initiatives with a strategy that minimizes risk and optimizes efficiency. We then tailor our robust services and technology solutions to integrate into your environment to make it a reality.
HQ: US
Languages: English
Provider Type: Service Firm
Services: Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems, Other
RTA Rescue: No
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Cmdmedtech

Website: cmdmedtech.com
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Connected Hardware (IoT/WiFi/Bluetooth)
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Securitypattern

Securitypattern offers specialized cybersecurity solutions for the medical device industry, ensuring compliance and protecting patient data.

Securitypattern is a dedicated provider of cybersecurity services tailored for the unique challenges within the medical device sector. They focus on safeguarding sensitive patient information and ensuring regulatory compliance for medical device manufacturers and healthcare organizations. Their expertise lies in identifying and mitigating cyber threats specific to connected medical devices, from development through deployment and ongoing operation. Securitypattern helps clients achieve robust security postures, maintain trust, and navigate the complex regulatory landscape of medical device cybersecurity.
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
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Coesecurity

Coesecurity provides specialized cybersecurity solutions for the medical device industry, ensuring compliance and security for connected health technologies.

Coesecurity is a dedicated provider of cybersecurity services tailored specifically for the unique challenges of the medical device sector. They focus on safeguarding connected health technologies throughout their lifecycle, from development to deployment and ongoing operation. Their expertise helps medical device manufacturers and healthcare organizations meet stringent regulatory requirements and protect sensitive patient data from evolving cyber threats. Coesecurity's solutions are designed to ensure the integrity, confidentiality, and availability of medical devices, thereby enhancing patient safety and trust in digital health solutions.
Website: coesecurity.com
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Connected Hardware (IoT/WiFi/Bluetooth)
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Velentiummedical

Velentiummedical is a specialized firm focused on medical device cybersecurity, ensuring the safety and security of connected healthcare technologies.

Velentiummedical is dedicated to safeguarding the integrity and security of medical devices within the healthcare ecosystem. They offer specialized expertise in medical device cybersecurity, addressing the unique challenges and vulnerabilities associated with connected health technologies. Their services are crucial for manufacturers and healthcare providers aiming to comply with stringent regulations and protect patient data from cyber threats. By focusing on this critical niche, Velentiummedical helps ensure that the advancements in medical technology are matched by robust security measures, fostering trust and reliability in digital healthcare solutions.
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
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Aerstone

©2026 William Grant & Sons Ltd Terms & Conditions | Privacy & Cookies Notice Registered in Scotland

medical device cybersecurity: ©2026 William Grant & Sons Ltd Terms & Conditions | Privacy & Cookies Notice Registered in Scotland. Registered Number SC131772 This content is intended only for those over the legal drinking age in their country. Please share mindfully. Welcome to Aerstone. The Single Malt of two choices. Please verify your age before continuing.
Website: aerstone.com
HQ: Girvan, UK
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), SBOM Management (Software Tool)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: SPDX, SWID
RTA Rescue: Yes
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L4b Software

OEM Value at a Glance Consolidate legacy medical device hardware onto a single i.MX95 platform, maintain deterministic real-time behavior, and introduce Android-based UI using a container-based mixed-criticality architecture designed for …

medical device cybersecurity: OEM Value at a Glance Consolidate legacy medical device hardware onto a single i.MX95 platform, maintain deterministic real-time behavior, and introduce Android-based UI using a container-based mixed-criticality architecture designed for … The Startup Dream vs Regulatory Reality Building a medical device startup is about speed, ingenuity, and solving real healthcare challenges. Early-stage founders work relentlessly to create working prototypes, validate preclinical … In the early stages of medical device development, platform infrastructure decisions are often delayed in favor of speed and flexibility. But choosing a compliance-ready OS early—before clinical trials begin—can save …
Website: l4b-software.com
HQ: San Jose, USA
Languages: English
Provider Type: Both
Services: Threat Modeling & Risk Analysis
Submission Stage: Pre-Submission (Planning)
Device Types: Connected Hardware (IoT/WiFi/Bluetooth)
RTA Rescue: No
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Layer8security

Layer8security specializes in medical device cybersecurity, offering expert solutions to protect sensitive healthcare data and ensure regulatory compliance.

Layer8security is a dedicated provider of cybersecurity solutions specifically tailored for the medical device industry. They understand the unique challenges and stringent regulatory requirements within healthcare, focusing on safeguarding patient data and ensuring the integrity of medical devices. Their expertise helps organizations navigate the complex landscape of medical device cybersecurity, offering comprehensive strategies to mitigate risks and maintain compliance with industry standards. By partnering with Layer8security, healthcare providers and device manufacturers can enhance their security posture and build trust in their digital health ecosystems.
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
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Sekurno

Discover key vulnerabilities and security trends shaping the biotech industry — based on insights from leading companies and analysts.

medical device cybersecurity: Discover key vulnerabilities and security trends shaping the biotech industry — based on insights from leading companies and analysts. When security is reduced to a checkbox exercise, it fosters a false sense of safety. In a digital landscape shaped by rapid change and AI-driven threats, that approach is no longer acceptable. That’s where we come in. We take the time to understand your real risks. Our solutions are built to safeguard what matters most — and to support the growth and resilience of your business.
Website: sekurno.com
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Scnsoft

Scnsoft is a leading provider of medical device cybersecurity solutions, ensuring compliance and safeguarding sensitive patient data.

Scnsoft specializes in comprehensive cybersecurity services tailored for the medical device industry. They offer robust solutions to protect against evolving threats, ensuring regulatory compliance and the integrity of patient information. Their expertise covers risk assessment, vulnerability management, and secure development lifecycle integration for medical devices. Scnsoft is committed to enhancing the security posture of healthcare organizations and device manufacturers, fostering trust and safety in the digital health landscape.
Website: scnsoft.com
HQ: Kharkiv, Ukraine
Languages: English
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
RTA Rescue: No
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Avaniaclinical

Avaniaclinical provides specialized cybersecurity solutions for the medical device industry, ensuring the safety and integrity of connected healthcare technologies.

Avaniaclinical is a dedicated provider of cybersecurity services tailored specifically for the medical device sector. They focus on safeguarding connected medical devices and healthcare systems from evolving cyber threats. Their expertise helps manufacturers and healthcare organizations maintain compliance, protect patient data, and ensure the uninterrupted operation of critical medical technologies. By addressing the unique vulnerabilities within the medical device landscape, Avaniaclinical plays a vital role in enhancing patient safety and trust in digital health solutions.
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
RTA Rescue: No
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L9group

L9group offers specialized cybersecurity services for medical device companies, ensuring compliance and security throughout the product lifecycle.

L9group is a dedicated provider of cybersecurity solutions tailored for the unique challenges within the medical device industry. They focus on helping manufacturers navigate the complex regulatory landscape and secure their devices against evolving cyber threats. Their expertise spans from early-stage product development through post-market surveillance, ensuring that security and compliance are integrated at every step. By partnering with L9group, medical device companies can enhance their product security, protect patient data, and maintain trust with regulatory bodies and end-users.
Website: l9group.com
Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
RTA Rescue: No
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Cybersecurity Bureauveritas

Provider Type: Service Firm
Services: Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
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Finitestate

Finitestate offers specialized cybersecurity solutions for medical devices, ensuring compliance and patient safety in the healthcare sector.

Finitestate is a leading provider of cybersecurity solutions specifically tailored for the unique challenges of medical devices. In an era where connected medical technology is rapidly advancing, securing these devices is paramount to protecting patient data and ensuring the integrity of healthcare operations. Finitestate's expertise lies in identifying vulnerabilities, implementing robust security measures, and maintaining compliance with stringent industry regulations. Their services are designed to safeguard medical devices throughout their lifecycle, from development to deployment and ongoing management. By partnering with Finitestate, healthcare organizations and medical device manufacturers can significantly reduce their risk of cyber threats, maintain operational continuity, and uphold the highest standards of patient safety and trust. Their focus on the medical device cybersecurity sector means they understand the critical interplay between technology, patient care, and regulatory requirements. This specialized knowledge allows them to offer proactive and effective solutions that address the evolving threat landscape. Whether it's securing implantable devices, diagnostic equipment, or hospital network infrastructure connected to medical devices, Finitestate provides comprehensive protection.
Website: finitestate.io
HQ: USA
Languages: English
Provider Type: Software Platform
Services: SBOM Management (Software Tool), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: CycloneDX, SPDX
RTA Rescue: No
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Onekey

Keep your connected devices secure and compliant by design. Meet the software designed for manufacturers and operators to avoid risks along the whole lifecycle – on autopilot.

medical device cybersecurity: Keep your connected devices secure and compliant by design. Meet the software designed for manufacturers and operators to avoid risks along the whole lifecycle – on autopilot. Know exactly what’s in your code. Get a detailed overview of your Software Bill Of Materials (SBOM) in just one click. No source code or network access needed. Create, import or override your component lists to keep your connected products secure and compliant. Let our platform detect and prioritize any known or unknown firmware vulnerabilities for you. 24/7. Always maintain an overview with our impact assessments of CVEs or Zero-Day threats. Mitigate risks and avoid incidents in a fraction of time.
Website: onekey.com
HQ: Düsseldorf, DE
Languages: English
Provider Type: Both
Services: SBOM Management (Software Tool), Vulnerability Management (Post-Market), Threat Modeling & Risk Analysis
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
SBOM Formats: CycloneDX, SPDX, Other
RTA Rescue: No
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C2a Sec

We're committed to protect your privacy. C2A Security uses the information you provide to us to contact you about our products and services. You may unsubscribe from these communic

medical device cybersecurity: We're committed to protect your privacy. C2A Security uses the information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, please review our Privacy Policy . Accelerate innovation while strengthening product security – transforming cybersecurity into a competitive advantage and unlocking greater business value. From embedded systems to cloud-connected devices – Ensure robust cybersecurity from design through deployment across sectors such as healthcare, manufacturing, critical infrastructure, mobility and more.
Website: c2a-sec.com
HQ: Jerusalem, Israel
Languages: English
Provider Type: Software Platform
Services: SBOM Management (Software Tool), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: SPDX, CycloneDX
RTA Rescue: No
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Cybellum

Cybellum brings the entire product security workflow into one dedicated platform, allowing device manufacturers to keep the connected products they build cyber-secure and cyber-compliant.

medical device cybersecurity: Cybellum brings the entire product security workflow into one dedicated platform, allowing device manufacturers to keep the connected products they build cyber-secure and cyber-compliant. Cybellum brings the entire product security workflow into one dedicated platform, allowing device manufacturers to keep the connected products they build cyber-secure and cyber-compliant. Create high fidelity, complete SBOMs & assets by merging binaries, source code and uploaded SBOM files. Then Auto-fix, validate and manage the approval process across teams.
Website: cybellum.com
Provider Type: Both
Services: SBOM Management (Software Tool), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Ready for 510(k)/MDR Submission
Device Types: Connected Hardware (IoT/WiFi/Bluetooth)
SBOM Formats: CycloneDX, SPDX
RTA Rescue: No
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Cybeats

By clicking 'Accept', you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.

medical device cybersecurity: By clicking 'Accept', you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them, except for Necessary Cookies which are required to provide core website functionality. When categories that have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. You can see a list of cookies assigned to each category and detailed information on those cookies in the Privacy Policy tab. The most comprehensive management solution to store, enrich, distribute, and continuously monitor your SBOMs at scale.
Website: cybeats.com
HQ: Canada
Languages: English
Provider Type: Software Platform
Services: SBOM Management (Software Tool), Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
SBOM Formats: CycloneDX, SPDX, Other
RTA Rescue: No
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Fossa

By submitting, I agree to receive periodic emails from FOSSA & accept the FOSSA Privacy Policy.

medical device cybersecurity: By submitting, I agree to receive periodic emails from FOSSA & accept the FOSSA Privacy Policy. Consolidate SCA, BCA, and Container Security into a single solution that scales to 1000s of developers. Eliminate vendor overlap, reduce false positives & unify security posture management across open source packages, binaries and containers.
Website: fossa.com
HQ: San Francisco, US
Languages: English
Provider Type: Software Platform
Services: SBOM Management (Software Tool), Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
SBOM Formats: CycloneDX, SPDX, Other
RTA Rescue: No
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Interlynk

components, licensing, and risks while streamlining compliance across your software supply chain.

medical device cybersecurity: components, licensing, and risks while streamlining compliance across your software supply chain. Interlynk automates SBOMs, manages open source risks, monitors suppliers, and prepares you for the post-quantum era, all in one trusted platform. Interlynk automates SBOMs, manages open source risks, monitors suppliers, and prepares you for the post-quantum era, all in one trusted platform.
Website: interlynk.io
HQ: USA
Languages: English
Provider Type: Software Platform
Services: SBOM Management (Software Tool), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Submission Stage: Pre-Submission (Planning)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
SBOM Formats: CycloneDX, SPDX
RTA Rescue: No
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Apurva Joshi

RAC-certified Regulatory Affairs professional with 7+ years of global experience in Class I, II, and III medical devices and IVDs, including software-enabled and digital medical devices.

Website: linkedin.com
HQ: Natick, US
Jurisdictions: EU, UK, CH, US
Countries: US, CA
Languages: English
Provider Type: Service Firm
Submission Stage: Pre-Submission (Planning), Ready for 510(k)/MDR Submission, RTA Fix (FDA Refusal Response)
Device Types: Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth), Hospital/Enterprise Systems
RTA Rescue: No
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Comprehensive Buyer's Guide

1. Who Needs Medical Device Cybersecurity Support?

Section 524B of the FD&C Act applies when a device meets the FDA definition of a “cyber device” — it includes software, can connect to the internet, and has characteristics that could make it vulnerable to cybersecurity threats.[1]

If you are submitting a 510(k), PMA, De Novo, PDP, or HDE for a cyber device, you must include specific cybersecurity information in the premarket submission.[1] This directory is built for teams that need to assemble or verify that cybersecurity evidence quickly (SBOMs, threat models, testing evidence, and post‑market monitoring plans).

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26

2. What Section 524B Requires in Premarket Submissions

  • Plan to monitor, identify, and address post‑market vulnerabilities and exploits.[1]
  • Processes and procedures to provide reasonable assurance of cybersecurity.[1]
  • Software Bill of Materials (SBOM).[1]

Vendors in this directory help generate these artifacts and ensure they align with FDA expectations.

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26

3. FDA Guidance (Feb 2026): What Reviewers Expect

The FDA’s February 2026 guidance on medical device cybersecurity provides recommendations on device design, labeling, and the cybersecurity documentation that should be included in premarket submissions.[1] It also explains how the guidance aligns with Section 524B for cyber devices.[1]

Use the guidance to shape your RFQ scope (what evidence you need, which tests to run, and how to present results).

References

  1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (U.S. Food and Drug Administration (FDA)) — 2026-02-03

4. How to Choose a Cybersecurity Vendor (Checklist)

  • Section 524B readiness: Can they deliver an SBOM and a post‑market vulnerability monitoring plan aligned with FDA requirements?[1]
  • Premarket documentation quality: Do they understand the FDA’s cybersecurity guidance for submission content and labeling?[2]
  • Device fit: SaMD vs. connected hardware vs. hospital systems; ensure the vendor has relevant device experience.
  • Testing depth: Confirm whether they provide manual penetration testing, threat modeling, or only automated scanning.
  • Post‑market support: Ask how they handle vulnerability monitoring, coordinated disclosure, and patching support.
  • RTA rescue capability: If you’re under deadline, verify that they can deliver missing artifacts quickly.

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26
  2. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (U.S. Food and Drug Administration (FDA)) — 2026-02-03

5. RTA Readiness for 510(k) Cybersecurity Submissions

The FDA uses Refuse‑to‑Accept (RTA) policy and acceptance checklists to determine whether a 510(k) submission is administratively complete for review.[1] Missing required elements can lead to an RTA and resubmission delays. If you’re close to a deadline, prioritize vendors who can produce missing cybersecurity artifacts quickly and in a format consistent with FDA expectations.

References

  1. Acceptance Checklists for 510(k)s (U.S. Food and Drug Administration (FDA)) — 2022-04-21

6. EU MDR/IVDR Reference: MDCG 2019‑16

For EU submissions, the Medical Device Coordination Group (MDCG) published MDCG 2019‑16, a guidance document focused on cybersecurity for medical devices under MDR/IVDR. It is commonly used to structure EU‑facing cybersecurity documentation and expectations.[1]

References

  1. MDCG 2019-16 — Guidance on Cybersecurity for Medical Devices (European Commission (MDCG)) — 2020-06-01

Frequently Asked Questions

Q1: What is a “cyber device” under FDA Section 524B?

FDA defines a cyber device as a medical device that includes software, can connect to the internet, and has characteristics that could make it vulnerable to cybersecurity threats.[1] If your device meets that definition, Section 524B applies to your premarket submission.

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26

Q2: Which submissions are in scope for Section 524B?

Section 524B applies to premarket submissions for cyber devices, including 510(k), PMA, PDP, De Novo, and HDE submissions, as described in FDA’s FAQs.[1]

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26

Q3: What does Section 524B require in a premarket submission?

FDA’s FAQ explains that premarket submissions for cyber devices must include: a plan to monitor and address post‑market vulnerabilities, processes and procedures to provide reasonable assurance of cybersecurity, and an SBOM (Software Bill of Materials).[1]

References

  1. Cybersecurity in Medical Devices — Frequently Asked Questions (FAQs) (U.S. Food and Drug Administration (FDA)) — 2025-06-26

Q4: Which FDA guidance should I follow for cybersecurity submissions?

The FDA’s February 2026 guidance Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions provides recommendations on device design, labeling, and cybersecurity documentation to include in premarket submissions.[1]

References

  1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (U.S. Food and Drug Administration (FDA)) — 2026-02-03

Q5: How do 510(k) RTA checklists affect cybersecurity submissions?

FDA uses Refuse‑to‑Accept (RTA) policy and acceptance checklists to determine whether a 510(k) submission is administratively complete for review. Missing required elements can lead to an RTA and delay review.[1]

References

  1. Acceptance Checklists for 510(k)s (U.S. Food and Drug Administration (FDA)) — 2022-04-21

Q6: Is there EU guidance for medical device cybersecurity?

Yes. The Medical Device Coordination Group (MDCG) published MDCG 2019‑16, a guidance document on cybersecurity for medical devices under MDR/IVDR.[1]

References

  1. MDCG 2019-16 — Guidance on Cybersecurity for Medical Devices (European Commission (MDCG)) — 2020-06-01

Related Regulatory Services

EU Authorized Representative (EU AR) UK Responsible Person (UK RP) Swiss Authorized Representative (CH-REP) Person Responsible for Regulatory Compliance (PRRC) EU+UK Cosmetics Compliance DSA Article 13 Representative

Provider Comparison Table

Provider CoverageKey Features Languages Response SLA
TÜV SÜD Request quote English, German Request quote
Intertek Request quote English Request quote
TÜV Rheinland Request quote English, German Request quote
UL Solutions Request quote English Request quote
Applus+ Laboratories Request quote English Request quote
Medcrypt Request quote Request quote
Blue Goat Cyber Request quote English Request quote
UL Solutions Request quote Request quote
TÜV SÜD Request quote Request quote
Clearwater Request quote English Request quote

Sources & Official Guidance

About This Guide

This guide is written for manufacturers and regulatory teams comparing medical device cybersecurity services, SBOM platforms, and specialized testing firms. It summarizes how to align vendor selection with FDA Section 524B requirements and current FDA cybersecurity guidance, while noting EU MDR/IVDR cybersecurity references where relevant.

We focus on practical buyer decisions: required artifacts, testing scope, post‑market monitoring expectations, and RTA readiness.

How we compiled this: We reviewed FDA guidance on medical device cybersecurity (Feb 2026), FDA’s Section 524B FAQs, and EU MDCG 2019‑16. Content is structured for procurement and regulatory readiness. Always confirm requirements with FDA or your notified body and legal/regulatory counsel.

Last Updated: 2026-03-05
Reviewed by: Cruxi Regulatory Affairs Team (medical device cybersecurity focus)
Cruxi - Regulatory Compliance Services