Before launching medical device products, companies must familiarize themselves with strict and complex review standards and analyze the vast amount of information in the drug administration's guidance documents. The company urgently needed an intelligent solution to enhance knowledge management efficiency and improve the approval rate to boost its market competitiveness.
Numerous and Strict Review Standards for Product Launch
￮Cumbersome Perusal of Drug Administration Documents: Preparing products for market launch requires compliance with multiple drug administration guidelines, demanding significant time for deep analysis.
￮Heavy Review Training: Review training covers multiple fields such as technology, clinical functions, and requires multiple cross-departmental meetings for thorough study.
￮Manual Compilation of Historical Replies from the Drug Administration: Organizing past documents from the drug administration requires a significant amount of manual copy-pasting, leading to high error rates and time consumption.
￮Difficulty in Quickly Identifying Key Information: Quickly locating key elements in stylistically varied documents is highly challenging.
￮High Costs of Manual Data Cleaning: Documents in PDF format, despite the use of OCR processing, still require extensive manual data cleaning, leading to high costs.
￮High Cost and Error-Prone Manual Copying: Manual copying often results in data format loss, high error rates, and consumes a lot of time and effort.
￮Knowledge Extraction is Time-Consuming and Labor-Intensive: The process of converting document knowledge into actionable insights is arduous and time-intensive when done manually.
