Using @SOP-042 and @ISO 14971, assess whether SOP-042 meets the residual-risk requirements, and draft a gap assessment.
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Fill @QMS-form-017 using @SOP-042 and @Risk-management-file.
Read QMS-form-017(template)
Read SOP-042 · Risk-management-file
Fill fields 12/12 · ✓ each cell sourced
Filled QMS-form-017 generated (see right). Every cell value carries an internal-source citation.✓ verified
Assess ISO 14971 applicability to the BP Monitor (12 requirements).
Retrieve ISO 14971 all clauses
judge applicability clause by clause · ✓ 9 applicable / 3 to review
Of 12 requirements, 9 apply and 3 need review (§7 quantitative, §9 post-market, §10 reporting). Each cites a regulatory paragraph.✓ verified