Reach IEC_62304_2006 readiness without rebuilding your policy programme

IEC_62304_2006 doesn't just dictate document templates — it shapes which controls auditors test, what evidence they ask for, and which gaps surface first during diligence. Getting it wrong creates renewal slippage, audit findings, and stalled customer deals.

• • Issued by IEC with global recognition.
• • Directly shapes policy families including Medical Device, Secure Software Development — these are the artefacts assessors open first.
• • Common artifacts include Policy.
• • Obligation model: Mandatory In Scope — meaning you need defensible reasoning for in-scope vs out-of-scope decisions, not just signed policies.

The platform turns IEC_62304_2006 from a PDF of requirements into a live operating model — policies, training, evidence, and audit-export packs that update in lock-step when the standard or your business changes.

• • Adopt IEC_62304_2006 once and Quick Policy seeds the right policy families (Medical Device, Secure Software Development) with applicability rationale your auditor can follow.
• • Common artifacts include Policy.
• • Review cadence is enforced at ~365 days so policies don't silently expire ahead of recertification.
• • Standard updates (IEC_62304_2006 revisions, errata, regulator guidance) trigger an applicability re-check across your active policies — not a full rewrite.