Siemens Digital Industries Software offers solutions for leading companies in the medical device and pharmaceutical industries that recognize the need for a platform to answer product development challenges. Our proven, flexible solutions help speed up innovation in pharmaceutical and medical device development, ensure quality, reduce costs and maintain adherence to ever-changing global regulations, including FDA compliance.
Design
Control
Design
Excellence
Labeling &
Submissions
Design
Transfer
Operational
Excellence
Personalization &
Additive
Manufacturing
Post Market
Surveillance
Design Control
Data-driven, model-based controls for Requirements, Risk, Product Definition, and V&V traceability results in higher accuracy, predictability and faster time to market clearance
- Requirements Specificatin
- Risk Management
- Systems Specificatin
- Verificatin & Validation Management
- Dcuments & Change Management
- DHF & DMR / TF
Design Excellence
Multi-disciplinary design collaboration, combined with multi-physics simulations for optimized performance of competitively differentiated, premium-value devices
- Systems Engineering
- Multi-Discipline Design & Data management: mechanical, electrnics, software, formulation
- Digital Twins f Product
- Engineering BOM & Cnfiguration Management
Labeling & Submissions
Integrating labeling with product development and manufacturing operations results in error-proofed and efficiently constructed labeling, configured for all countries and regions
- Artwrk & Label Management
- Instructins for Use (IFU) Management
- Unique Device Identifier (UDI) submissins
- On-demand Printing & Inspectins
Design Transfer
Optimize global operations & quality via advanced manufacturing process design consolidating manufacturing plants, or when necessary, divest quickly, efficiently and with confidence
- Manufacturing Prcess & Plant Design
- Manufacturing BOM & Cnfiguration Management
- Digital Twins f Production
- Supply Chain Cllaboration
- ERP & MES Integratin
Operational Excellence
Use manufacturing models to schedule and execute production, enforcing routes, inspections, and rework, resulting in high quality, efficient, and compliant production
- Prduction Scheduling
- Manufacturing Executin: Operations Routing, inspection & rework
- DHR
- Quality management integratin
- Manufacturing Analytics
Personalization & Additive Manufacturing
Enable diagnoses and therapies using individual patient or population data to provide optimized treatment and efficacy
- Precisin med. collaboration with Providers
- Data-driven therapy design using imaging & pathlogy reports
- Additive Manufacturing fr small lot sizes
Post Market Surveillance
Using big data analytics and artificial intelligence (AI), track and predict KPI’s to compare and proactively respond to performance issues and concerns
- Prduct Performance KPI Analytics
- Rot Cause Discovery
- Reprting for CAPA’s and submissions