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Name Comment Information EN Latest update
chevron Technical File (TF) closed folder
TF-FOR-03-EN_MDR-Checklist Not available in current plan. . Book a free demo
TF-FOR-04-EN_Classification-MDR Not available in current plan. . Book a free demo
TF-FOR-05-EN_IVDD-Checklist Not available in current plan. . Book a free demo
TF-FOR-06-EN_IVDR-Checklist-Annex_I Not available in current plan. . Book a free demo
TF-FOR-07-EN_IVDD-IVDR-Gap-Analysis (Excel) Not available in current plan. . Book a free demo
TF-FOR-08-EN_IVDR-Checklist-Annex_II_III Not available in current plan. . Book a free demo
TF-FOR-09-EN_Classification-IVDR Not available in current plan. . Book a free demo
TF-FOR-09-EN_Classification-IVDR (Excel) Not available in current plan. . Book a free demo
TF-TPL-05-EN_Declaration-of-Conformity Not available in current plan. . Book a free demo
TF-TPL-06-EN_System-Overview-IVD Not available in current plan. . Book a free demo
TF-LIS-01-EN_CE-marked-Devices Not available in current plan. . Book a free demo
chevron Design Input (DI) closed folder
DI-FOR-01-EN_Checklist-Stakeholder-Requirements Not available in current plan. . Book a free demo
DI-TPL-01-EN_Indended-Use Not available in current plan. . Book a free demo
DI-TPL-02-EN_Stakeholder-Requirements Not available in current plan. . Book a free demo
DI-TPL-03-EN_Intended-Purpose-IVD Not available in current plan. . Book a free demo
DI-TPL-04-EN-Formulation-Stencil_IP_IVD Not available in current plan. . Book a free demo
chevron Software File (SW) closed folder
SW-FOR-01-EN_Software-Requirements-Specification-Checklist Not available in current plan. . Book a free demo
SW-FOR-02-EN_Software-Architecture-Checklist Not available in current plan. . Book a free demo
SW-FOR-05-EN_Software-Release Not available in current plan. . Book a free demo
SW-FOR-06-EN_Code-Review-Checklist Not available in current plan. . Book a free demo
SW-FOR-08-EN_Template-Design-Review Not available in current plan. . Book a free demo
SW-FOR-09-EN_Software-Safety-Classification Not available in current plan. . Book a free demo
SW-FOR-10-EN_DiGA-Requirements-Checklist Not available in current plan. . Book a free demo
SW-TPL-01-EN_SW-Development-Plan Not available in current plan. . Book a free demo
SW-TPL-02-EN_Configuration-Management-Plan Not available in current plan. . Book a free demo
SW-TPL-03-EN_Software-Requirements-Specification Not available in current plan. . Book a free demo
SW-TPL-04-EN_Software-Architecture Not available in current plan. . Book a free demo
SW-TPL-06-EN_System-Test-Protocol Not available in current plan. . Book a free demo
SW-TPL-06-EN_System-Test-Protocol (Excel) Not available in current plan. . Book a free demo
SW-TPL-07-EN_Machine-Learning Not available in current plan. . Book a free demo
SW-TPL-08-EN_Software-Description Not available in current plan. . Book a free demo
SW-TPL-09-EN_Cybersecurity-Documentation Not available in current plan. . Book a free demo
SW-TPL-10-EN_Software-Full-Report Not available in current plan. . Book a free demo
SW-TPL-11-EN_SW-Verification-Plan Not available in current plan. . Book a free demo
SW-TPL-12-EN_SW-Verification-Report Not available in current plan. . Book a free demo
SW-TPL-13-EN_Validation-Plan Not available in current plan. . Book a free demo
SW-TPL-14-EN_Validation-Report Not available in current plan. . Book a free demo
SW-LIS-01-EN-List-of-documents_SW-file Not available in current plan. . Book a free demo
chevron Risk Management File (RM) closed folder
RM-TPL-00-EN_Riskmanagement-File Not available in current plan. . Book a free demo
RM-TPL-01-EN_Risk-Management-Plan Not available in current plan. . Book a free demo
RM-TPL-02-EN_Risk-Management-Acceptance-Analysis-Assessment (Excel) Not available in current plan. . Book a free demo
RM-TPL-03-EN_Risk-Management-Report_compact Not available in current plan. . Book a free demo
RM-TPL-04-EN_Risk-Management-Report_detailed Not available in current plan. . Book a free demo
RM-TPL-05-EN_Risk-Management-Table_IVD Not available in current plan. . Book a free demo
RM-TPL-06-EN_Risk-Management-Table-IVD-Production Not available in current plan. . Book a free demo
RM-FOR-01-EN_Checklist-Risk-Management-Plan Not available in current plan. . Book a free demo
RM-FOR-02-EN_Checklist-Risk-Management-Analysis-and-Evaluation Not available in current plan. . Book a free demo
RM-FOR-03-EN_Checklist-Risk-Management-Report Not available in current plan. . Book a free demo
RM-FOR-04-EN_PHA-TR24971-2020 Not available in current plan. . Book a free demo
RM-FOR-05-EN_Hazard-Examples-ISO14971-2019 Not available in current plan. . Book a free demo
chevron Usability File / Human factors (HF) closed folder
HF-TPL-01-EN_Usability-Engineering-File-UEF Not available in current plan. . Book a free demo
HF-TPL-02-EN_Usability-Evaluation-Plan-UP Not available in current plan. . Book a free demo
HF-TPL-03-EN_Usability-Evaluation-Protocol-UEP Not available in current plan. . Book a free demo
HF-TPL-04-EN_Usability-Evaluation-Summary-Report-UESR Not available in current plan. . Book a free demo
HF-TPL-05-EN_Usability-Engineering-File-UEF-UOUP Not available in current plan. . Book a free demo
chevron Clinical Evaluation (CE) closed folder
CE-TPL-01-EN_Clinical-Evaluation-Report Not available in current plan. . Book a free demo
CE-TPL-02-EN_Clinical-Evaluation-Plan Not available in current plan. . Book a free demo
CE-TPL-04-EN_SSCP Not available in current plan. . Book a free demo
CE-TPL-05-EN_Literature-search-protocol (Excel) Not available in current plan. . Book a free demo
CE-TPL-06-EN_Declaration-of-Interests Not available in current plan. . Book a free demo
CE-TPL-12-EN_Literature-search-report Not available in current plan. . Book a free demo
CE-TPL-13-EN_Demonstration-of-Equivalence (Excel) Not available in current plan. . Book a free demo
chevron Post-Market-Clinical-Follow-Up (CF) closed folder
CF-TPL-01-EN_PMCF-Plan Not available in current plan. . Book a free demo
CF-TPL-02-EN_PMCF-Report Not available in current plan. . Book a free demo
chevron Development (PD) closed folder
PD-TPL-01-EN_Design-and-development-plan-IVD Not available in current plan. . Book a free demo
PD-TPL-02-EN_Product-Requirements-Specification-IVD Not available in current plan. . Book a free demo
PD-TPL-03-EN_Product-Design-Specification-IVD-Assay Not available in current plan. . Book a free demo
PD-FOR-01-EN_Design-Review-Checklist-IVD Not available in current plan. . Book a free demo
PD-FOR-02-EN_Design-Freeze-IVD Not available in current plan. . Book a free demo
PD-FOR-03-EN_Design-Transfer-IVD Not available in current plan. . Book a free demo
PD-FOR-04-EN_IVD-Release-Product-Development Not available in current plan. . Book a free demo
PD-LIS-01-EN_Traceability-Product-Development Not available in current plan. . Book a free demo
PD-TPL-04-EN_Design-and-development-plan Not available in current plan. . Book a free demo
PD-TPL-05-EN_Product-requirement-specification Not available in current plan. . Book a free demo
PD-TPL-06-EN_Product-Design-Specification Not available in current plan. . Book a free demo
PD-FOR-05-EN_Design-Review-Checklist Not available in current plan. . Book a free demo
PD-FOR-06-EN_Design-Freeze Not available in current plan. . Book a free demo
PD-FOR-07-EN_Design-Transfer Not available in current plan. . Book a free demo
PD-FOR-08-EN_Release-Product-Development Not available in current plan. . Book a free demo
chevron IVD-Performance Evaluation (PE) closed folder
PE-TPL-01-EN_Performance-Evaluation-Plan Not available in current plan. . Book a free demo
PE-TPL-02-EN_Performance-Evaluation-Report Not available in current plan. . Book a free demo
PE-TPL-03-EN_Literature-Search-Report Not available in current plan. . Book a free demo
PE-TPL-04-EN_Scientific-Validity-Report Not available in current plan. . Book a free demo
PE-TPL-05-EN_Analytical-Performance-Plan Not available in current plan. . Book a free demo
PE-TPL-06-EN_Analytical-Performance-Report Not available in current plan. . Book a free demo
PE-TPL-07-EN_Analytical-Performance-Plan-SW Not available in current plan. . Book a free demo
PE-TPL-08-EN_Analytical-Performance-Report-SW Not available in current plan. . Book a free demo
PE-TPL-10-EN_PMPF-Plan Not available in current plan. . Book a free demo
PE-TPL-11-EN_PMPF-Report Not available in current plan. . Book a free demo
PE-TPL-12-EN_Stability-Testing-Plan Not available in current plan. . Book a free demo
PE-TPL-16-EN_Stability-Testing-Protocol Not available in current plan. . Book a free demo
PE-TPL-13-EN_Stability-Testing-Report Not available in current plan. . Book a free demo
PE-TPL-14-EN_Summary-of-Safety-and-Performance Not available in current plan. . Book a free demo
PE-TPL-15-EN_SOTA Not available in current plan. . Book a free demo
PE-FOR-01-EN_Literature-search-protocol (Excel) Not available in current plan. . Book a free demo
chevron Labeling (LA) closed folder
LA-TPL-01-EN_Checklist-Label-Product-Packaging Not available in current plan. . Book a free demo
LA-TPL-02-EN_Template-IFU-MDR Not available in current plan. . Book a free demo
LA-TPL-03-EN_Checklist-IFU Not available in current plan. . Book a free demo
LA-TPL-04-EN_Template-IFU-IVD Not available in current plan. . Book a free demo
chevron Biocompatibility (BC) closed folder
BC-TPL-01-EN_Evaluation-of-Biocompatibility Not available in current plan. . Book a free demo
Name Comment Information EN Latest update
chevron QM-Manual (QM) closed folder
QM-QM-01-EN_QM-Manual Not available in current plan. . Book a free demo
QM-QM-02-EN_Quality-Policy Not available in current plan. . Book a free demo
QM-QM-03-EN_Quality-Objectives Not available in current plan. . Book a free demo
chevron Management Review & Audit (MR / IA / UA) closed folder
MR-SOP-01-EN_Management-Review Not available in current plan. . Book a free demo
MR-SOP-02-EN_Data-Analysis Not available in current plan. . Book a free demo
MR-TPL-01-EN_Management-Review-Report Not available in current plan. . Book a free demo
MR-FOR-01-EN_Data-Analysis Not available in current plan. . Book a free demo
IA-SOP-01-EN_Internal-Audit Not available in current plan. . Book a free demo
IA-LIS-01-EN_Action-Plan (Excel)  Not available in current plan. . Book a free demo
IA-TPL-01-EN_Audit-Program Not available in current plan. . Book a free demo
IA-TPL-02-EN_Audit-Plan Not available in current plan. . Book a free demo
IA-TPL-03-EN_Audit-Report Not available in current plan. . Book a free demo
UA-SOP-01-EN_Unannounced-Audits Not available in current plan. . Book a free demo
chevron Corrective and preventive actions (CA) closed folder
CA-SOP-01-EN_Corrective-and-Preventive-Actions Not available in current plan. . Book a free demo
CA-FOR-01-EN_CAPA-Form Not available in current plan. . Book a free demo
CA-LIS-01-EN_CAPA-List (Excel)  Not available in current plan. . Book a free demo
chevron Document & Record Control (DC) closed folder
DC-SOP-01-EN_Control-of-Documents-and-Records Not available in current plan. . Book a free demo
DC-LIS-01-EN_SOP-Checklist Not available in current plan. . Book a free demo
DC-LIS-02-EN_Processes-Documentation-ISO-13485-MDR Not available in current plan. . Book a free demo
DC-LIS-05-EN_Processes-Documentation-ISO-13485-IVDR Not available in current plan. . Book a free demo
DC-LIS-03-EN_Glossary Not available in current plan. . Book a free demo
DC-LIS-04-EN_Document-List (Excel)  Not available in current plan. . Book a free demo
DC-TPL-01-EN_SOP-Template Not available in current plan. . Book a free demo
DC-TPL-02-EN_List-Template (Excel)  Not available in current plan. . Book a free demo
DC-TPL-05-EN_Template-for-Form-and-Template Not available in current plan. . Book a free demo
chevron Human Resources & Training (HR) closed folder
HR-SOP-01-EN_Recruiting-and-Training Not available in current plan. . Book a free demo
HR-TPL-01-EN-Job-Description Not available in current plan. . Book a free demo
HR-FOR-01-EN_Training-Record Not available in current plan. . Book a free demo
HR-FOR-02-EN_Effectiveness-Check Not available in current plan. . Book a free demo
HR-FOR-03-EN_Privacy-Statement Not available in current plan. . Book a free demo
HR-FOR-04-EN-Training_Plan Not available in current plan. . Book a free demo
chevron Infrastructure (IS) closed folder
IS-SOP-01-EN_Computer-System-Validation Not available in current plan. . Book a free demo
IS-SOP-02-EN_Measuring-Equipment Not available in current plan. . Book a free demo
IS-SOP-03-EN_Control-and-Monitoring-of-Work-Environment Not available in current plan. . Book a free demo
IS-SOP-05-EN_Infrastructure-and-Maintenance Not available in current plan. . Book a free demo
IS-LIS-01-EN_List-of-Computerized-Systems Not available in current plan. . Book a free demo
IS-LIS-01-EN_List-of-Computerized-Systems (Excel) Not available in current plan. . Book a free demo
IS-LIS-02-EN_List-of-measuring-instruments Not available in current plan. . Book a free demo
IS-LIS-02-EN_List-of-measuring-instruments (Excel) Not available in current plan. . Book a free demo
IS-LIS-03-EN_List-of-infrastructure-elements Not available in current plan. . Book a free demo
IS-TPL-01-EN_Evaluation-Computerized-Systems Not available in current plan. . Book a free demo
IS-TPL-02-EN-Validation-Plan Not available in current plan. . Book a free demo
IS-TPL-03-EN_Test-protocol Not available in current plan. . Book a free demo
IS-TPL-03-EN_Test-protocol (Excel) Not available in current plan. . Book a free demo
IS-TPL-04-EN_Validation-Report Not available in current plan. . Book a free demo
IS-TPL-05-EN_Work-environment-conditions-Product Not available in current plan. . Book a free demo
chevron Development and Product Management closed folder
CE-SOP-01-EN_Clinical-Evaluation Not available in current plan. . Book a free demo
PD-SOP-01-EN_Problem-Resolution Not available in current plan. . Book a free demo
PD-SOP-02-EN_Product-Development-IVD-Assay-Instrument Not available in current plan. . Book a free demo
PD-SOP-03-EN_Product-Development Not available in current plan. . Book a free demo
RM-SOP-01-EN_Risk-Management Not available in current plan. . Book a free demo
RM-SOP-02-EN_Riskmanagement-IVD Not available in current plan. . Book a free demo
RM-SOP-03-EN Not available in current plan. . Book a free demo
PE-SOP-01-EN_Performance-Evaluation Not available in current plan. . Book a free demo
PE-SOP-02-EN_Stability-Testing-IVD Not available in current plan. . Book a free demo
HF-SOP-01-EN_Usability-Engineering-Process Not available in current plan. . Book a free demo
SW-SOP-01-EN_Software-Development Not available in current plan. . Book a free demo
CF-SOP-01-EN_Post-Market-Clinical-Follow-Up Not available in current plan. . Book a free demo
BC-SOP-01-EN_Biocompatibility-assessment Not available in current plan. . Book a free demo
chevron Supplier Management & Procurement (SA, PS) closed folder
SA-SOP-01-EN_Tendering-and-Sales Not available in current plan. . Book a free demo
SA-TPL-01-EN_Non-Disclosure-Agreement Not available in current plan. . Book a free demo
PS-SOP-01-EN_Purchase Not available in current plan. . Book a free demo
PS-SOP-02-EN_Supplier-Selection-and-Evaluation Not available in current plan. . Book a free demo
PS-SOP-03-EN_Supplier-Surveillance Not available in current plan. . Book a free demo
PS-LIS-01-EN_Supplier-List (Excel) Not available in current plan. . Book a free demo
PS-FOR-01-EN_Supplier-Evaluation Not available in current plan. . Book a free demo
PS-FOR-02-EN_Checklist-Incoming-Goods-Distributors Not available in current plan. . Book a free demo
PS-FOR-03-EN_Checklist-Incoming-Goods-Importers Not available in current plan. . Book a free demo
PS-TPL-01-EN_QAA Not available in current plan. . Book a free demo
chevron Production & Service Delivery (SU, PR, LA, PSA, LG) closed folder
PR-SOP-01-EN_Production Not available in current plan. . Book a free demo
PR-TPL-01-EN_Production-run-sheet_Product_X Not available in current plan. . Book a free demo
PR-SOP-02-EN_Non-Conforming-Products Not available in current plan. . Book a free demo
PR-SOP-03-EN_Processvalidation Not available in current plan. . Book a free demo
PR-TPL-03-EN_Validationplan Not available in current plan. . Book a free demo
PR-TPL-02-EN_Validationmasterplan Not available in current plan. . Book a free demo
PR-TPL-04-EN_IQ-plan-and-report Not available in current plan. . Book a free demo
PR-TPL-05-EN_OQ-plan-and-report Not available in current plan. . Book a free demo
PR-TPL-06-EN_PQ-plan-and-report Not available in current plan. . Book a free demo
PR-TPL-07-EN_Validation-Report Not available in current plan. . Book a free demo
PSA-SOP-01-EN_Control-of-contaminated-products Not available in current plan. . Book a free demo
LA-SOP-02-EN_UDI-Labeling-Tracking Not available in current plan. . Book a free demo
LA-LIS-01-EN_Device-identifiers (Excel) Not available in current plan. . Book a free demo
LA-LIS-02-EN_Language-Requirements-EU Not available in current plan. . Book a free demo
LG-SOP-01-EN_Warehouse-and-Shipping Not available in current plan. . Book a free demo
SU-SOP-01-EN_Support Not available in current plan. . Book a free demo
chevron Change Management (CC) closed folder
CC-SOP-01-EN_Change-Management Not available in current plan. . Book a free demo
CC-FOR-01-EN_Change-Request Not available in current plan. . Book a free demo
CC-LIS-01-EN_Change-List (Excel) Not available in current plan. . Book a free demo
chevron Post-Market Surveillance, Feedback (CH, PM) closed folder
CH-SOP-01-EN_Complaint-Handling Not available in current plan. . Book a free demo
PM-SOP-01-EN_Post-Market-Surveillance Not available in current plan. . Book a free demo
PM-SOP-02-EN_Post-Market-Surveillance-IVD Not available in current plan. . Book a free demo
PM-TPL-01-EN_PMS-Report Not available in current plan. . Book a free demo
PM-TPL-05-EN_PMS-Report-IVD Not available in current plan. . Book a free demo
PM-TPL-02-EN_PSUR Not available in current plan. . Book a free demo
PM-TPL-06-EN_PSUR-IVD Not available in current plan. . Book a free demo
PM-TPL-03-EN_PMS-Plan Not available in current plan. . Book a free demo
PM-TPL-07-EN_PMS-Plan-IVD Not available in current plan. . Book a free demo
PM-TPL-04-EN_Market-Analysis (Excel)  Not available in current plan. . Book a free demo
PM-TPL-08-EN_Data-search-protocol (Excel) Not available in current plan. . Book a free demo
chevron Authorities and Regulatory Affairs (TF, RU, VI) closed folder
TF-SOP-02-EN_Product-Release-FDA Not available in current plan. . Book a free demo
TF-SOP-03-EN_Placing-on-the-market-MDR Not available in current plan. . Book a free demo
TF-SOP-04-EN_Placing-on-the-market-IVDR Not available in current plan. . Book a free demo
VI-SOP-02-EN_Incident-Reporting-and-Recall-USA Not available in current plan. . Book a free demo
VI-SOP-03-EN_Reporting-of-Incidents-and-FSCA-EU Not available in current plan. . Book a free demo
VI-FOR-02-EN_Incident-Reporting_USA Not available in current plan. . Book a free demo
VI-FOR-03-EN_Incident-Evaluation-EU Not available in current plan. . Book a free demo
RU-SOP-01-EN_Regulatory-Update Not available in current plan. . Book a free demo
RU-LIS-01-EN_List-of-regulations-to-be-monitored Not available in current plan. . Book a free demo
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