🖥️ OPALE SNITEM

Audit platform developed over 1 year for SNITEM, on a permanent contract at Soft Concept, in collaboration with Nexialist

📝 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.

🛠️ Technologies used

C#, HTML, CSS, JavaScript
Internal tools:
- Net-Survey: questionnaire creation
- Ethnos: survey data analysis
- Web Reports: application development and deployment

🗂️ Application Structure

👨‍💼 Administrator Profile (SNITEM)

🔍 Status Review - Diagnosis: consultation of indicators to understand the overall distribution of TD (Technical Documentation)
✅ Decision: summary of decisions made within the company regarding the product portfolio
🕹️ Monitoring: summary of management elements entered by manufacturers
🔐 Access Management: management of rights for manufacturers and all users

👨‍🏭 Manufacturer Profile (Adherent)

📦 Products: entry of data (market, financial, technical...)
📋 QMS: management of quality management systems (ISO 13485)
📁 TD: data entry and regulatory decision within the MDD/MDR transition
🏢 Company Data: name, workforce, capital

⚙️ Additional Features

📄 Data Import via Excel form
📊 Data Viz "micro/macro"
📖 User Guide (documentation and deeper insights)

📈 Usage

👉 Administrator / SNITEM: user management and access to the "macro dashboard"
👉 Manufacturers: data entry and access to the "micro dashboard"