Governance, risk & compliance

Health Canada Medical Device Cybersecurity June 2019 guidance

Health Canada's pre-market cybersecurity expectations for medical devices, from the Guidance Document "Pre-market Requirements for Medical Device Cybersecurity", finalized June 2019.

It covers cybersecurity risk management within the device risk-management process, secure design, a cybersecurity bill of materials, verification and validation testing, and the information a licence application must carry. It also sets postmarket expectations inside the same document rather than a separate one: proactive monitoring for new vulnerabilities in the device and its third-party components, and a formalized vulnerability disclosure process.

The requirements overlap substantially with FDA section 524B, so a manufacturer selling on both sides of the border builds one program and evidences it twice - which is the point of assessing them side by side.

Assessment tiers & levels Lavawall supports

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

How Lavawall® helps you get to Health Canada Medical Device Cybersecurity compliance

Most of Health Canada Medical Device Cybersecurity 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 Health Canada Medical Device Cybersecurity, and tracks your posture continuously instead of once a year at audit time.

• Assess your current state against Health Canada Medical Device Cybersecurity 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 Health Canada Medical Device Cybersecurity 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.