← List New Assessment Configuration cfg-9b806abf Draft Archive
Basic Info
Design Conformity Review FY2026
Annual design-conformity review, Class II devices
Design History File & QMS Records ⌄
Always included in the LLM context, on every item.
▤ISO 13485 Quality Manual.pdfStandard
▤Design Control SOP.pdfProcedure
2 / 240 pinned
Source File
Upload an Excel file containing the evaluation items.
Drop your Excel file here
Drag and drop, or browse to upload .xlsx, .xls, .xlsm
Browse files
✓ 125 imported | ● Sheet1 copy Column B 1~125 / 125 rows Reset
X Design Conformity Checklist FY2026.xlsx XLSX41.2 KB128 rows
ABCD
＋ Sheet1 Sheet1 copy ▦  —  ———  ＋  60%
Extracted Items 125 items Search items…
#✎ Evaluation Item TextSheet
1Are design inputs traceable to user needs and risk analysis outputs?Sheet1 copy
2Is biological evaluation complete for every patient-contact material?Sheet1 copy
3Was the sterilisation process revalidated after the process change?Sheet1 copy
4Does design verification cover the specified cap retention force?Sheet1 copy
5Are complaint trends reviewed against regulatory reporting thresholds?Sheet1 copy
6Is software lifecycle documentation maintained to IEC 62304?Sheet1 copy
Input Flow Configuration ＋ Add Step
Define questions shown to users at run time. Answers can be used for RAG metadata filters or item filters.
Step 1🗑
Options⌄
RAG Database Filtering
Options
Class II🗑
Class III🗑
＋ Add
device_class4 values
doc_type3 values
If you specify a RAG database metadata key, the values for that key will be shown as options at run time.
Item Filter exclusion conditions
For each evaluation item, you can set exclusion conditions based on user answers (optional). Matched items are marked as “Not applicable”. Items without conditions are always evaluated.
1 Are design inputs traceable to user needs and risk analysis outputs? Sheet1 copy ✕
IF Which device class is this assessment for?⌄ IS Class II Class III THEN IT IS 🗑
2Is biological evaluation complete for every patient-contact material?Sheet1 copy
3Was the sterilisation process revalidated after the process change?Sheet1 copy
4Does design verification cover the specified cap retention force?Sheet1 copy
5Are complaint trends reviewed against regulatory reporting thresholds?Sheet1 copy
6Is software lifecycle documentation maintained to IEC 62304?Sheet1 copy
Evaluation Choices the AI agent’s verdict set
ConformsCited evidence in the design history file meets the requirement
Does not conformNo qualifying evidence found, always state the residual risk
Out of scopeDoes not apply to this device class or intended use
Cannot judgeEvidence is fragmentary or ambiguous either way
No informationNothing related was found in the searched records
Your verdicts, your wording — the agent may only choose from this set.
Output Settings
Click a variable to insert it into the field.
{{config_name}}{{execution_id}} {{date}}{{datetime}} {{input_1}}
{{config_name}}_{{date}}_{{execution_id}}
Preview: Design Conformity Review FY2026_20260828_00000000-0000-0000-0000-000000000000
Choose which column of the source file each result is written back to.
ResultComment EvidenceReference
ResultColumn I CommentColumn M EvidenceColumn Q ReferenceColumn R
ExcelPDFCSV
Prompt
Sent to the LLM for each assessment item. Click a variable to insert it.
{{question_text}}{{rag_context}} {{item_number}}{{input_1}} 

              


              
              

                
Review Configuration

                

                  
Configuration NameDesign Conformity Review FY2026

                  
RAG DatabaseDesign History File & QMS Records

                  
Pinned Reference Documents2 documents

                  
Source FileDesign Conformity Checklist FY2026.xlsx

                  
Number of Extracted Items125

                  
Input Flow Steps3

                  
Item Filter Conditions10 items have conditions

                  
Evaluation ChoicesConforms, Does not conform, Out of scope, Cannot judge, No information

                  
Output File Name{{config_name}}_{{date}}_{{execution_id}}

                

              


            


            
            

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You have successfully configured an assessment.

            
Design Conformity Review FY2026 is published. Every run from here applies this exact configuration — the same standard, item after item.

            

              125 items240 documents5 verdictsExcel + PDF