| Company / Fase | Fase 0 - Inicio | Fase 1 - Concepto | Fase 2 - Desarrollo | Fase 3 - Industrialización | Fase 4 - Producción | Fase 5 - Post-mercado |
|---|---|---|---|---|---|---|
|
Estudio de mercado Análisis de materiales Insights de usuario |
Concepto design Prototipado rápido Prototipos 3D Moldes de silicona Prueba de concepto |
Refinamiento de diseño Prototipos funcionales Validación de diseño |
Diseño para fabricación (DFM) Especificaciones finales de diseño | Soporte de diseño a producción |
Evolución de producto Mejoras de diseño |
|
Patent search Technical feasibility Architecture |
Requirements analysis System concept Risk analysis |
Device development Testing Verification |
DFM Industrial engineering Pre-compliance testing |
Producción support Process optimization Equipment assembly | Continuous improvement |
| REGULATORY |
Regulatory pathway Intended use draft Classification |
Regulatory strategy Clinical strategy |
Technical file draft Risk management Clinical eval |
Submission CE/FDA technical file Compliance review | Audit support |
PMS Vigilance |
| SOFTWARE |
Software feasibility Architecture |
UX/UI Requirements (IEC 62304) |
Software development Verification & validation Cybersecurity |
HW/SW integration System validation |
Deployment Maintenance |
Updates Cloud support |
|
Electronic components analysis Feasibility |
Architecture design Component selection |
PCB development Testing |
Industrialización PCB Validation |
Producción electronics Equipment assembly Warehousing | Support & redesign |
|
Análisis de materiales - Consumables Injection feasibility |
Mold concept Material selection | Plastic prototypes |
Tooling Mold validation |
Injection production Assembly Blistering | Optimization |
|
Parts analysis Dismolding feasibility | Mold design concept | Prototype molds |
Final mold manufacturing Validation | Producción molds | Maintenance |
|
Material/parts analysis Treatments | Process definition | Process validation | Industrialización treatments |
Producción treatments Assembly | Optimization |
|
Análisis de materiales Finishing feasibility | Process selection | Finishing validation | Industrial finishing |
Producción finishing Assembly | Improvements |
