Secure your medical device and pass FDA 510(k) or PMA faster

Full cybersecurity compliance from design to post-market.

Need to submit SaMD / Non-SaMP - 510(k) or PMA ?

Need help with cybersecurity?

Need FDA / NMPA or any Worldwide regulatory consulting?

Need help with a QMS Implementation?

Need help with warning letter?

Need help with incident response ?

We deliver cybersecurity assessments within 7 business days for new products and in as little as 2 business days for existing products.

Our experts support over 420 annual submissions to the FDA and NMPA, delivering industry-leading expertise with a 100% success rate and no regulatory findings or queries.

A digital illustration of a syringe with a glowing light tube through the middle, connected to a cluster of dark gears and icons related to security and healthcare on the left, and a block labeled 'FDA NMP' on the right, with a floating sphere featuring medical and heart rate symbols above.

Why Five10K?

  • Prevent costly 510(k) / PMA submission delays

  • Eliminate cybersecurity gaps before FDA finds them

  • Stay compliant throughout the entire product lifecycle

  • Focused exclusively on medical device cybersecurity and AI and Quantum Safe SaMD, SiMD.

  • Deep understanding of Regulatory expectations

  • Covers full lifecycle (TPLC) - not just testing

  • Combines engineering + regulatory expertise + Cybersecurity expertise

  • Fixed SLA timelines, fixed outcomes.

  • We support organizations in achieving ISO 27001 certification and prepare executive leadership for cybersecurity audits, including structured Cyber Tabletop exercises and business continuity readiness programs.

How it works:

  1. Analyze your device & regulatory gaps

  2. Build cybersecurity & compliance plan

  3. Execute testing & documentation

  4. Submit and pass 510(k) / PMA - up to 7 Days 100% success rate.

Don’t Let Cybersecurity Delay Your Product Launch

Get a clear picture of your cybersecurity readiness — before the FDA does.

Schedule Your Free Assessment

Latest News

A silver pen resting on an open document with printed text discussing cybersecurity standards and regulations, including references to the FDA, RTA, SBOM, and Five9K's automated approval tools.

FDA Intensifies "Refuse to Accept" (RTA) Enforcement for Incomplete Cyber Documentation

The FDA has strictly adopted a zero-tolerance policy for medical device submissions lacking comprehensive cybersecurity architectures. Recent data shows a spike in RTA decisions for files missing a dynamic Software Bill of Materials (SBOM) or robust threat modeling. Discover how Five10K’s automated submission tools guarantee a 100% acceptance rate for your cyber documentation

Open notebook with a 3D printed emblem in the shape of a shield with a heartbeat line, surrounded by a circular band. The band contains words 'Design,' 'Develop,' and 'Post-Market,' with small icons. The page features printed text about AI-powered innovations in medical device security and lifecycle management.

Navigating New FDA Cybersecurity Expectations for AI-Driven Medical Devices

As Artificial Intelligence and Machine Learning transform patient care, the FDA is rapidly evolving its security requirements for Software as a Medical Device (SaMD). Securing these dynamic algorithms requires continuous, automated vulnerability management. Learn how Five10K secures the entire lifecycle of your AI-powered innovations from design to post-market

A digital tablet displaying a presentation about market clearance, cyber strategy, and post-market management. On the screen, there is a circular diagram with elements labeled design, develop, and post-market, with a world map in the background. A small wooden block with the text "Five10K Automated Solutions" is on the tablet.

Post-Market Surveillance Takes Center Stage in Recent FDA Audits Summary

Securing market clearance is no longer the finish line. The FDA is increasing its scrutiny on how manufacturers handle real-world vulnerabilities, CVEs, and patch management post-launch. Failure to maintain an active post-market cyber strategy can lead to warning letters. See how Five10K provides total peace of mind with our automated vulnerability and patch management services.

Cybersecurity Is Now a Business Risk -

Not Just a Technical One

A digital graphic showing a shield with a medical cross, DNA strands, and circuitry, representing medical device cybersecurity. There are four sections underneath describing the process: pre-market risk management, documentation and SBOM, submission support, and post-market response, with respective icons and summaries.

FDA cybersecurity requirements are stricter than ever.

  • Missing documentation, weak risk management, or incomplete SBOM can lead to:

  • Refused-to-Accept (RTA) decisions

  • Months of delay in product launch

  • Costly rework and resubmission

  • Increased risk of recalls post-market

  • For CEOs, this means lost revenue, delayed growth, and increased regulatory exposure.

Two people sitting at a table and preform an audit for cybersecurity to a new SaaMD, one typing on a laptop and the other taking notes in a notebook, with a glass of water, a pen, a vase with calla lilies, and decorative objects in the background.

We Help You Get Approved - Faster and With Confidence

FDA expectations - before submission.

We don’t just test your product.

We prepare it for approval

End-to-end cybersecurity support (Pre + Post Market)

Built specifically for FDA 510(k) and global regulations

Designed to reduce delays and eliminate rework.

Diagram illustrating the steps in cybersecurity compliance process, including assessment, documentation, submission support, and post-market monitoring, with labeled blocks on wooden blocks and a stylized globe icon.

A Clear Path from Design to Approval

  1. Identify what’s missing for FDA readiness

  2. Remediation & Documentation
    SBOM, threat modeling, risk management

  3. Submission Support
    Ensure your cybersecurity package is complete

  4. Post-Market Compliance
    Continuous monitoring and vulnerability management

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What This Means for Your Business

Faster time-to-market

Lower regulatory risk

Reduced engineering rework

Increased confidence in submission success

Book a Free Cyber Readiness Review

Whether you are preparing for an upcoming FDA/NMPA submission or handling warning letter, navigating complex hospital security questionnaires, or looking to automate your SBOM and vulnerability management, our experts are here to help

Get In Touch

ProductSecurity@five10K.com

USA, Europe, China, Japan, Brazil, Worldwide 24/7 Services and Support.

MedTech Industry Cybersecurity Compliance Standards

International Standards (ISO/IEC):

  • IEC 81001-5-1: Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle.

  • ISO 14971: Medical devices — Application of risk management to medical devices.

  • IEC 62304: Medical device software — Software life cycle processes.

  • ISO/IEC 27001: Information security management systems (ISMS).

  • ISO/IEC 27034: Application security.

US Regulatory (FDA)

  • FDA Premarket Submission: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

  • FDA Post-market Management: Post-market Management of Cybersecurity in Medical Devices.

  • FD&C Act Section 524B: Ensuring Cybersecurity of Medical Devices.

  • SBOM: Software Bill of Materials.

  • CVD: Coordinated Vulnerability Disclosure.

Industry Frameworks & Guidelines

  • IMDRF N60: Principles and Practices for Medical Device Cybersecurity.

  • IMDRF N70: Post-market Cybersecurity Support of Medical Devices.

  • ANSI/AAMI SW96: Standard for medical device security — Security risk management.

  • UL 2900-2-1: Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.

  • NIST Cybersecurity Framework (CSF): Often used as a baseline for organizational security.

  • MITRE ATT&CK for Healthcare: Framework for understanding medical-specific cyber threats.

China (NMPA - National Medical Products Administration)

  • YY/T 1843: Cybersecurity requirements for medical devices (The Chinese equivalent to international cybersecurity standards).

  • NMPA Guideline for Cybersecurity Registration of Medical Devices: Specific requirements for technical documentation in submissions.

  • GB/T 35273: Information security technology — Personal information security specification.

  • China Data Security Law (DSL): Impacting how medical data is handled and stored.

  • China Personal Information Protection Law (PIPL): Similar to GDPR, affecting connected medical devices.

South Korea (MFDS - Ministry of Food and Drug Evaluation)

  • YY/T 1843: Cybersecurity requirements for medical devices (The Chinese equivalent to international cybersecurity standards).

  • NMPA Guideline for Cybersecurity Registration of Medical Devices: Specific requirements for technical documentation in submissions.

  • GB/T 35273: Information security technology — Personal information security specification.

  • China Data Security Law (DSL): Impacting how medical data is handled and stored.

  • China Personal Information Protection Law (PIPL): Similar to GDPR, affecting connected medical devices.

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Person flipping through a sample risk assessment report with fabric and tile swatches on a wooden table.

End-to-End Cybersecurity for Medical Devices

From Product Planning to End-of-Life — Fully Aligned with Regulatory Requirements

We provide comprehensive cybersecurity services across the entire lifecycle of your medical device — ensuring compliance, reducing risk, and accelerating your path to market.

Plan Phase - Define Cybersecurity from Day One

Build your product on a secure and compliant foundation.

Our services include:

  • Cybersecurity risk assessment based on product intended use and architecture

  • Identification of attack surfaces and threat scenarios

  • Definition of mandatory cybersecurity requirements aligned with regulatory expectations (FDA and global standards)

  • Integration of cybersecurity requirements into system specifications and development plans

Outcome:
Early alignment with regulatory expectations, reducing the risk of costly redesigns and delays later in development

Design & Development Phase - Ensure Secure Implementation

We support your engineering teams in implementing cybersecurity correctly across all system layers.

Our services include:

  • Secure code review, including automated scanning tools

  • Verification and validation of cybersecurity requirements implementation

  • Risk assessment at software, firmware, and hardware levels

  • Operating system hardening and secure configuration validation

  • Security patching and update management processes

  • Vulnerability management across internal components and supply chain

  • Third-party software, components, and vendor risk assessment

Outcome:
Reduced technical risk, improved product security posture, and readiness for regulatory submission

Verification & Validation (V&V) - Demonstrate Compliance

We perform objective cybersecurity testing aligned with regulatory expectations to support your submission.

Our services include:

  • Penetration testing conducted according to industry and regulatory standards

  • Fuzz testing to identify unexpected vulnerabilities and edge-case failures

  • Security verification aligned with FDA cybersecurity requirements

  • Support in preparing cybersecurity documentation for regulatory submissions

Outcome:
Increased confidence in submission success and reduced risk of Refused-to-Accept (RTA) decisions

Release to End-of-Life - Maintain Compliance in the Field

Cybersecurity is an ongoing process. We help you stay compliant and secure throughout the product lifecycle.

Our services include:

  • Continuous monitoring of vulnerabilities in deployed products

  • Ongoing compliance with evolving regulatory requirements

  • Vulnerability tracking, assessment, and remediation management

  • Incident response and cybersecurity event handling

  • Support for audits, reporting, and regulatory interactions

Outcome:
Reduced risk of recalls, regulatory exposure, and reputational damage

Customer & Market Support - Enable Your Commercial Success

We support your teams in addressing cybersecurity requirements from customers, hospitals, and partners.

Our services include:

  • Participation in meetings with customers, hospitals, and clinical organizations

  • Support in responding to cybersecurity questionnaires and due diligence processes

  • Assistance with cybersecurity-related contractual and legal requirements

  • Guidance on meeting healthcare IT and information security expectations

Outcome:
Shorter sales cycles, increased customer confidence, and removal of cybersecurity as a barrier to adoption

Final Note

We don’t just secure your product — we ensure it meets regulatory expectations and succeeds in the market

An illustration of a cybersecurity lab with professionals working on medical device security, featuring large diagrams, maps, and a digital medical device at the center with security icons, surrounded by people at computers, robotic arms, and informational boards about regulations, security, and device development.