MedTech Cybersecurity Standards

FDA guidance, AAMI consensus standards, ISO quality and risk frameworks, IEC software lifecycle, NIST cybersecurity controls - they overlap, conflict in places, and together define what reviewers expect. This hub maps the standards landscape and links each one to the services and guides that operationalize it.

Services

• Full-Service FDA Premarket Cybersecurity

  Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, and PMA submissions - traceable, complete, and aligned with current 524B guidance.

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting.

• Medical Device Threat Modeling

  Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.

• FDA-Compliant SBOM Services

  Machine- and human-readable SBOMs with NTIA minimum elements, vulnerability mapping, and end-of-support tracking - built for FDA review.

In-depth guides

• The MedTech Cybersecurity Standards DecoderA plain-English field guide to FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ANSI/AAMI SW96, ISO 14971, and 8 more medical device cybersecurity standards. What they require, how they connect, and what the FDA expects to see in your eSTAR premarket submission.
• The SPDF PlaybookSPDF PLAYBOOK · FDA CYBERSECURITY GUIDE The SPDF Playbook for FDA-Ready Medical Devices A practical, ungated guide to building a Secure Product Development Framework that FDA accepts. The eight pillars, the artifacts each one produces, and a pre-submission readiness checklist you can score yourself

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
• Section 524BFD&C Act Cyber Device RequirementsAdded by the Consolidated Appropriations Act, 2023, Section 524B gives the FDA explicit authority to require a complete cybersecurity package in every premarket submission for a cyber device, and to refuse submissions that lack one.
• ANSI/AAMI SW96Medical Device Security Risk ManagementThe consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
• AAMI TIR57Principles for Medical Device Security – Risk ManagementThe MedTech-specific extension of ISO 14971 for cybersecurity. Defines how to identify cybersecurity assets, threats, and vulnerabilities, then estimate, evaluate, and control the resulting risk.
• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.
• ISO 13485Medical Device Quality Management SystemThe international QMS standard for MedTech. Covers design controls, document control, CAPA, supplier management, and post-market surveillance. The QMSR final rule (effective Feb 2, 2026) harmonizes 21 CFR Part 820 with ISO 13485.
• ISO 14971Medical Device Risk ManagementThe umbrella risk-management standard for medical devices. Defines hazard identification, risk estimation, risk evaluation, risk control, and residual risk evaluation. Cybersecurity risks must be reconciled here so a security control never silently introduces a safety hazard.
• IEC 81001-5-1Health Software Security ActivitiesThe international standard the FDA points to for the Secure Product Development Framework (SPDF). Defines security activities at each lifecycle stage - planning, requirements, design, implementation, V&V, release, and post-market.
• IEC 62443-4-1Secure Product Development LifecycleIndustrial-strength secure-development-lifecycle requirements applied to connected medical devices.
• NIST CSF 2.0Cybersecurity FrameworkSix functions: Govern, Identify, Protect, Detect, Respond, Recover. Not MedTech-specific, but commonly used by health-system customers as their procurement bar - so device makers need to map their controls to it.
• eSTARElectronic Submission TemplateFDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.

From the blog

• AAMI TIR57 Risk Management for Medical DevicesA practical guide to AAMI TIR57 (R2023) and how it supports FDA’s Feb 2026 cybersecurity guidance - risk analysis, controls, and evidence.
• 21 CFR Part 820 and Medical Device CybersecurityUpdated October 26, 2024 The development, manufacturing, and management of medical devices require strict regulatory adherence to ensure these products' safety, effectiveness, and reliability. A key regulatory framework governing this process is 21 CFR Part 820, often called the Quality System Regul
• A New Era for Quality and Safety: What the FDA’s QMSR Means for CybersecurityFDA’s QMSR is now in effect. See why connected MedTech teams must build cybersecurity into the QMS - risk management, V&V, suppliers, and postmarket.

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