Cybersecurity is no longer optional—it’s critical to patient safety and regulatory success. As medical devices increasingly connect to apps, cloud platforms, and hospital networks, manufacturers must follow stringent cybersecurity practices throughout the entire product lifecycle.
At Blue Goat Cyber, we specialize in helping medical device manufacturers align with the most critical global standards, frameworks, and FDA guidance. This comprehensive guide covers the top cybersecurity standards for premarket submissions, postmarket monitoring, and secure development practices that support compliance and risk management.
Core Medical Device Cybersecurity Standards
1. ISO/IEC 27001 – Information Security Management Systems (ISMS)
Overview:
ISO 27001 provides a global framework for establishing and maintaining an organization-wide Information Security Management System (ISMS). It helps secure data, manage vendors, and implement technical controls.
Why It Matters:
Ideal for manufacturers managing protected health information (PHI), cloud platforms, or third-party integrations.
Example:
A company developing a cloud-based patient monitoring platform uses ISO 27001 to enforce data encryption, access control, and incident response.
Link: https://www.iso.org/standard/27001
2. ISO 14971 – Risk Management for Medical Devices
Overview:
ISO 14971 defines the risk management process for medical devices, including cybersecurity as a risk source that can impact safety and effectiveness.
Why It Matters:
Required for most FDA and EU MDR regulatory pathways and foundational for identifying and mitigating cyber threats.
Example:
An insulin pump manufacturer uses ISO 14971 to analyze Bluetooth jamming and unauthorized access scenarios, mapping them to patient harm.
Link: https://www.iso.org/standard/72704.html
3. AAMI TIR57 – Security Risk Management for Medical Devices
Overview:
AAMI TIR57 expands on ISO 14971 to address security-specific risks, including threat modeling, attack surface analysis, and likelihood scoring.
Why It Matters:
Highly relevant for FDA premarket submissions, particularly for connected or software-based medical devices.
Example:
A development team applies TIR57 to analyze security risks in a wearable ECG device and integrate mitigations into the design.
Link: https://webstore.ansi.org/standards/aami/aamitir572016
4. AAMI TIR97 – Postmarket Cybersecurity Risk Management
Overview:
AAMI TIR97 offers guidance for managing cybersecurity risks after launching a device, including vulnerability disclosure, patching, and monitoring.
Why It Matters:
Supports FDA postmarket guidance and helps organizations manage coordinated disclosures and field safety communications.
Example:
A firmware flaw is discovered in an implantable neurostimulator. TIR97 guides the patch process, user notification, and mitigation documentation.
Link: https://www.aami.org/detail-pages/product/aami-tir972019-r-2023-pdf-a152e000006j60oqaa
5. IEC 62304 – Medical Device Software Lifecycle Processes
Overview:
IEC 62304 standardizes secure software development and maintenance for medical devices. It covers planning, development, validation, and updates.
Why It Matters:
Required for embedded firmware, mobile apps, and SaMD products, especially in FDA and EU regulatory environments.
Example:
A smart inhaler team uses IEC 62304 to manage software configuration, versioning, testing, and documentation.
Link: https://www.iso.org/standard/38421.html
6. IEC 81001-5-1 – Security in Health Software Development Lifecycle
Overview:
This newer standard defines how to embed cybersecurity into software development processes, aligning with modern SDLC and FDA expectations.
Why It Matters:
Vital for developers using agile or DevSecOps models and those preparing FDA submissions under the 2023 guidance.
Example:
A SaMD platform applies IEC 81001-5-1 to implement secure code practices, static analysis, and access control from dev to deployment.
Link: https://www.iso.org/standard/76097.html
7. FDA Cybersecurity Guidance (2023 Final)
Overview:
This FDA guidance sets enforceable expectations for cybersecurity in premarket submissions (510(k), PMA, De Novo), including requirements for SBOMs, threat modeling, secure updates, and documentation of a Secure Product Development Framework (SPDF).
Why It Matters:
Required for most new FDA device submissions. Missing elements may trigger a Refuse to Accept (RTA) response.
Example:
A team submitting a wireless-connected glucose meter uses the guidance to include SBOM, threat analysis, and secure update architecture.
Supplemental Cybersecurity Frameworks and Best Practices
8. NIST SP 800-53 – Security and Privacy Controls
Overview:
This widely adopted NIST standard outlines security controls used across federal systems and is often used by healthcare and medical device vendors to secure enterprise and cloud environments.
Example:
A cloud-hosted health data platform implements access control, encryption, and auditing based on NIST SP 800-53.
Link: https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final
9. NIST SP 800-30 – Risk Assessments
Overview:
This standard outlines best practices for performing structured risk assessments, particularly around cybersecurity threats and system vulnerabilities.
Example:
A pen test team uses NIST 800-30 to evaluate the likelihood and impact of potential exploits in an internet-connected infusion pump.
Link: https://csrc.nist.gov/publications/detail/sp/800-30/rev-1/final
10. NIST SP 800-82 – Guide to ICS Security
Overview:
Focuses on securing control systems like those used in industrial and healthcare devices with real-time, actuator-based functionality.
Example:
A surgical robotics platform uses 800-82 to analyze and mitigate command injection and actuator hijacking risks.
Link: https://csrc.nist.gov/publications/detail/sp/800-82/rev-2/final
11. IMDRF Cybersecurity Principles and Practices
Overview:
It provides globally harmonized cybersecurity principles aligned with FDA and EU MDR expectations, covering risk management and lifecycle responsibility.
Example:
An international device manufacturer uses IMDRF guidance to unify cybersecurity planning across its U.S. and EU markets.
Link: https://www.imdrf.org/documents/principles-and-practices-medical-device-cybersecurity
12. UL 2900 Series – Software Cybersecurity for Connected Products
Overview:
This UL standard defines security testing and assurance criteria for network-connectable devices, including medical technology. It is often used for third-party certifications.
Example:
A surgical camera system vendor pursues UL 2900-2-1 certification to validate its cybersecurity posture to healthcare buyers.
Link: https://standardscatalog.ul.com/standards/en/standard_2900-1
13. IEC 62443-4-1 – Secure Product Development Lifecycle Requirements
Overview:
IEC 62443-4-1 is part of the industrial cybersecurity standard series but is increasingly applied to medical devices due to their embedded and connected nature. It defines a secure development lifecycle (SDL) for developing secure products, covering requirements like threat modeling, secure coding, vulnerability management, and patching.
Why It Matters:
This standard benefits manufacturers of embedded devices, IoT-enabled platforms, and network-connected components. It helps demonstrate that security is embedded in the entire development process, from planning through decommissioning.
Example:
A company developing a connected infusion pump applies IEC 62443-4-1 to structure its secure development practices, integrate vulnerability tracking into DevOps, and document cybersecurity controls for FDA review.
Link: https://webstore.iec.ch/en/publication/33615
14. IEC 60601-4-5 – Medical Electrical Equipment: Safety – Security in Essential Performance
Overview:
IEC 60601-4-5 is an extension of the foundational IEC 60601 family, which governs electrical safety and performance of medical devices. This part focuses on how cybersecurity threats impact essential performance and basic safety, aligning risk management with functional safety.
Why It Matters:
It bridges the gap between traditional safety standards and modern cybersecurity requirements, particularly useful for devices that deliver therapy, monitor critical functions, or interact with patient physiology.
Example:
A ventilator system manufacturer uses IEC 60601-4-5 to evaluate how a denial-of-service or unauthorized remote command could affect ventilation performance and patient safety.
Link: https://webstore.ansi.org/standards/IEC/iectr60601eden2021
Final Thoughts
Adopting these cybersecurity standards and aligning with FDA guidance gives your product a competitive edge—enhancing patient safety, accelerating time to market, and reducing regulatory risk. At Blue Goat Cyber, we help manufacturers map these frameworks into secure architectures, FDA-ready documentation, and real-world protection strategies.
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