Testing · Test Report Review

Read the report before
the auditor does.

Technical review of test reports against the applicable standard — identifying gaps, errors, and missing evidence before you submit your technical file.

Standards Conformance Review

We review test reports clause by clause against the applicable standard — verifying that the test configuration matches your device, that all required tests were performed, that pass criteria are correctly stated, and that conclusions are adequately supported by the data.

IEC 60601-1 EMC Reports Biocompatibility Software V&V
Gap Identification

Test reports from accredited labs are not always complete or correctly scoped for your specific device configuration. We identify missing clauses, incorrect device configurations, invalid sample states, and other gaps that would trigger a notified body or CDSCO query.

Compliance Statement Drafting

We draft the compliance statements and declaration of conformity referencing the reviewed test reports, ready for inclusion in your technical file or submission dossier.

Remediation Guidance

When gaps are found, we tell you precisely what additional testing or documentation is needed — and help you brief the lab on the retest scope so remediation is targeted and efficient.

Review Report

Annotated assessment of each test report with findings, gaps, and required actions.

Compliance Matrix

Standards clause mapping with test report references and conformity status.

Declaration of Conformity

DoC draft referencing applicable standards and test evidence, ready for authorised signature.

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