Data Characteristics for This Category
Medical device registration dossiers draw data from various sources. These include clinical trial reports, biocompatibility test reports, electromagnetic compatibility (EMC) test reports, software validation reports, and risk management reports. Most of these documents are in PDF format. Some raw data may be in Excel or database files. Core technical documents, such as design specifications and test standards, are relatively stable. Clinical data and regulatory requirements, however, change dynamically. For example, revisions to medical device classification catalogs or new technical guidelines are typically updated several times a year. Document structures often follow the National Medical Products Administration (NMPA) templates, including clear chapter titles and numbering. Fields and units involve physiological parameters (e.g., heart rate bpm, blood oxygen saturation SpO2 %), electrical performance indicators (e.g., voltage V, current mA), and material science data (e.g., biodegradation rate g/mol). Units are highly standardized.
Constraints on "Reference and Traceability" Due to These Characteristics
The complexity and dynamic nature of medical device registration dossiers impose specific requirements on reference and traceability. The coexistence of multiple document formats means the knowledge base needs robust multi-modal parsing capabilities. This ensures critical information from PDFs, Excel files, and other formats is accurately extracted. The stability of core technical documents allows for one-time, in-depth vectorization. The dynamic nature of regulatory and clinical data requires support for incremental updates and version management. This ensures referenced regulations are always the latest version. Standardized document structures help identify specific sections or paragraphs, such as "safety and effectiveness" or "clinical evaluation conclusions," through preset parsing rules, improving recall accuracy. Clear units for physiological and electrical parameters require accurate presentation of values and units in references to avoid ambiguity. For example, distinguishing between 95% blood oxygen saturation and 95 kPa pressure values. This dictates that the knowledge base needs specific mechanisms to identify and process number-unit combinations during chunking, vectorization, and retrieval.
Configuration Settings
| Configuration Item | Recommended Value | Rationale |
|---|---|---|
Chunk size (Chunk Length) | 500–800 characters | Accommodates common technical description paragraph lengths in dossiers, balancing contextual completeness and retrieval efficiency. |
Overlap Length | 100–150 characters | Ensures information at paragraph boundaries is not lost, providing sufficient bridging context, especially for cross-paragraph references. |
Recall count (Recall Count) | top 5–8 items | Given the rigor of dossiers, increasing recall count covers more potentially highly relevant original text snippets. |
Similarity threshold (Similarity Threshold) | 0.78–0.85 | Balances accuracy and recall rate. Avoids missing relevant but slightly differently phrased regulations or test results due to an excessively high threshold. |
maxContext | 3500–4000 tokens | Ensures sufficient capacity for multiple recalled snippets and their necessary surrounding context to support complex technical arguments. |
PARSE_FILE_TIMEOUT_SECONDS | 600 seconds | Addresses the parsing needs for large PDF files (e.g., clinical trial reports), preventing file processing failures due to timeouts. |
Three Common Mistakes
- Quoted source links in answers point incorrectly or are inaccessible. This happens when knowledge base file paths or external link mappings are not configured correctly.
- When generating answers, some key technical parameters or regulatory clauses are not cited. This may be because the document chunking granularity is too large, diluting relevant information, or the similarity threshold is set too high, failing to recall.
- Quoted source text snippets are incomplete, leading to missing context. This occurs when the
Overlap Lengthis set too low, or document parsing fails to correctly identify paragraph boundaries.
How to Confirm Proper Configuration
- Test with multiple typical dossier questions. Check if the original text snippets cited in each answer accurately correspond to the relevant content in the document.
- Verify that the document links cited in the answers are accessible and point to the correct location or section within the document.
- In the generated answers, check if the sources for key physiological parameters, electrical indicators, or regulatory clauses can be precisely traced back to specific sentences or tables in the original documents.
The values provided are common starting points and should be measured against your own samples.
Question material comes from public community discussions. Configuration values are common starting points and should be measured against your own samples. Verified on 2026-09-21.