Certifications and attestations

Medical Device Cybersecurity

FDA / IEC · Global

Cybersecurity for medical devices across the product lifecycle.

Issuer

FDA / IEC

Applies in

Global

Working with Medical Device Cybersecurity

What Medical Device Cybersecurity is

Cybersecurity for medical devices across the product lifecycle. It is issued by FDA / IEC and applies across every jurisdiction. Our assessors work against it directly, so what follows is the practitioner view rather than a restatement of the text.

Who it binds

Applicability turns on what you process and who regulates you, not on your size. If FDA / IEC sets your rules, or a customer contract names Medical Device Cybersecurity, you are in scope. We map that boundary first, because an over-drawn scope is the single most expensive mistake in any programme.

What an assessor looks for

Evidence that the control operated, not that it was written down. Expect sampling across the period, interviews with the control owners, and a request for the artefacts that prove the control ran on the days it was supposed to. Policies without operating evidence are the most common finding we raise.

How to get ready

Scope it, assess the gap against the current version, remediate in priority order, then collect evidence continuously rather than in the fortnight before the audit. Evidence lag is what slips dates, not the controls themselves.

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