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Acme MedTech Inc. is currently operating under the SaMD (Class II/III) profile. You have active target markets in the EU, US, and Canada.
Compliance Ratio
Compliance Gaps
Clause Overlaps
IMS Documents
Auditor High-Priority Gaps
Obligation clauses with zero associated operational evidence.
Human resources
Establish competence, provide training, and ensure awareness of personnel regarding QMS obligations.
Design and development outputs
Outputs shall be provided in a form suitable for verification against design and development inputs, and approved prior to release.
Design and development validation
Validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
Compliance Action Items
Assign and track engineering or QARA corrections linked directly to standard gaps.
| Compliance Status | Task / Clause | Assignee Name | Due Date |
|---|---|---|---|
Establish electronic document control review protocolLinked Clause: 4.2.3 — Control of documents... Write toolchain automation scripts linking document sign-offs directly to production release environments. | Sean (DevOps Lead) | 2026-05-25 | |
Add automated code verification hooksLinked Clause: 7.3.6 — Design and development verification... Configure build checks in GitHub actions to block commits that lack QA peer-review approvals. | Sean (DevOps Lead) | 2026-05-30 |
