Governance, risk & compliance

Medical Device Security Lifecycle 2026

The consensus standards and industry practice a device manufacturer builds to in order to satisfy the regulators.

Four sources: IEC 81001-5-1:2021, which defines security activities across the health software product life cycle and is the standard both FDA and Health Canada expect a manufacturer to be working from; ANSI/AAMI SW96:2023, the American National Standard for security risk management, published November 2023, which extends ISO 14971 safety risk management to security risk rather than replacing it; AAMI TIR57:2016/(R)2023, the technical information report SW96 builds on; and the Health Sector Coordinating Council's Medical Device and Health IT Joint Security Plan version 2. 0, published March 2024, a voluntary secure-product-development framework written by the sector for the sector.

None of these is a certification. They are how the work gets done, and they are what an FDA reviewer expects to see referenced when a submission explains its method.

Assessment tiers & levels Lavawall supports

Lavawall assesses Medical Device Security Lifecycle at every level below, so you can start where you are and step up as your program matures.

How Lavawall® helps you get to Medical Device Security Lifecycle compliance

Most of Medical Device Security Lifecycle comes down to technical controls you have to run and prove: keeping systems patched, hardening configuration, detecting breaches early, backing up what matters, controlling access, and keeping evidence that all of it actually happened. Lavawall® runs those controls across Windows, macOS, Linux, and Microsoft 365 / Google Workspace from one console, maps them to Medical Device Security Lifecycle, and tracks your posture continuously instead of once a year at audit time.

• Assess your current state against Medical Device Security Lifecycle in the Lavawall GRC module, with the questionnaire and control set built in.
• Remediate the gaps with the same platform — automated patching, configuration fixes, backups, and access review — not a separate project.
• Evidence everything with timestamped, exportable records auditors, insurers, and clients accept.

Related

Lavawall® supports Medical Device Security Lifecycle as part of a built-in catalogue of compliance frameworks. Framework requirements are summarized for planning purposes; always confirm the current official text before certifying.