Audit platform developed over 1 year for SNITEM , on a permanent contract at Soft Concept , in collaboration with Nexialist
π Presentation
It's a management tool for overseeing the various stages leading to MDR (Medical Device Regulation) certification, on SNITEM (French National Association of Medical Technologies Industries) initiative.
π οΈ Technologies used
C#, HTML, CSS, JavaScript
Internal tools:
ποΈ Application Structure
π¨βπΌ Administrator Profile (SNITEM)
π Status Review - Diagnosis : consultation of indicators to understand the overall distribution of TD (Technical Documentation)
β
Decision : summary of decisions made within the company regarding the product portfolio
πΉοΈ Monitoring : summary of management elements entered by manufacturers
π Access Management : management of rights for manufacturers and all users
π¨βπ Manufacturer Profile (Adherent)
π¦ Products : entry of data (market, financial, technical...)
π QMS : management of quality management systems (ISO 13485)
π TD : data entry and regulatory decision within the MDD/MDR transition
π’ Company Data : name, workforce, capital
βοΈ Additional Features
π Data Import via Excel form
π Data Visualization "micro/macro"
π User Guide (documentation and deeper insights)
π Usage
π Administrator / SNITEM : user management and access to the "macro dashboard"
π Manufacturers : data entry and access to the "micro dashboard"
Β©Soft Concept 2023
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