├── LICENSE.md ├── README.md └── templates ├── clinical_evaluation ├── checklist-clinical-evaluation.md ├── clinical-evaluation-plan.md ├── clinical-evaluation-report.md ├── literature-evaluation-table.md └── sop-clinical-evaluation.md ├── data_protection ├── data-protection-statement-website.md ├── employee-data-protection-and-confidentiality-agreement.md ├── list-of-data-processing-activities.md └── technical-and-organizational-measures.md ├── general ├── checklist-essential-requirements-mdd.md ├── checklist-gspr-mdr.md ├── instructions-for-use.md ├── intended-use.md ├── mdr-classification-document.md └── mdr-declaration-of-conformity.md ├── information_security ├── 27001-mapping.md ├── information-security-controls.md ├── information-security-policy-and-scope.md └── sop-information-security-risk-assessment.md ├── performance_evaluation ├── performance-evaluation-plan-ivdd.md └── performance-evaluation-report-ivdd.md ├── qms ├── 13485-mapping.md ├── capa │ ├── list-capa.md │ └── sop-capa.md ├── document-and-record-control │ ├── document-list-dlqms.md │ └── sop-document-record-control.md ├── human-resources │ ├── appointment-letter-prrc.md │ ├── list-of-medical-device-consultants.md │ ├── list-of-training-documentation.md │ ├── sop-human-resources-administration.md │ └── training-record.md ├── internal-audit │ ├── audit-plan.md │ ├── audit-program.md │ ├── audit-report.md │ └── sop-internal-audit.md ├── list-of-regulatory-requirements.md ├── management-review │ ├── management-review-report.md │ └── sop-management-review.md ├── post-market-surveillance │ ├── periodic-safety-update-report.md │ ├── post-market-clinical-follow-up-plan.md │ ├── post-market-clinical-follow-up-report.md │ ├── post-market-surveillance-plan.md │ └── sop-post-market-surveillance.md ├── purchasing │ ├── list-of-qualified-suppliers.md │ ├── sop-purchasing.md │ └── supplier-checklist.md ├── quality-manual-policy-objectives.md ├── software-validation │ ├── software-list.md │ ├── software-validation-form.md │ └── sop-software-validation.md ├── sop-feedback-management.md ├── sop-product-certification-and-registration.md ├── sop-sales.md ├── sop-update-of-regulations.md └── vigilance │ ├── field-safety-notice.md │ ├── incident-assessment-form.md │ └── sop-vigilance.md └── techdoc ├── 14971 ├── 14971-mapping.md ├── risk-management-cybersecurity-checklist.md ├── risk-management-plan.md ├── risk-management-report.md └── risk-table-fmea.md ├── 62304 ├── 62304-mapping.md ├── algorithm-validation-report.md ├── bug-fixes-documentation-list.md ├── change-evaluation-list.md ├── checklist-software-release.md ├── checklist-software-requirements-review.md ├── checklist-user-needs-review.md ├── instructions-on-data-acquisition.md ├── instructions-on-data-annotation.md ├── list-of-medical-devices.md ├── software-architecture-checklist.md ├── software-architecture-description.md ├── software-development-maintenance-plan.md ├── software-requirements-list.md ├── 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