Medical Technology Industry Solution
Compliance
Built-in compliance ensures end-to-end coverage of ISO 13485, FDA 21 CFR Part 11, and EU MDR requirements, providing audit-ready processes, complete documentation, and full traceability without extra administrative effort.
✓ Audit Trail
Tamper-proof recording of all system changes, user activities, and data modifications
✓ Electronic Signature
Digital signatures in accordance with CFR and ISO standards for critical processes, fully digital and without media breaks
✓ Distributor Integration
Automatic access to current market prices, stock levels, and supplier terms
✓ Integrated DMS
Central management of technical documents, SOPs, and production data
✓ Workflow-Supported Control
Automated approval chains and compliance-driven processes across quality management and production
Product Lifecycle Management
Regulated product development from the first concept to market release: centrally manage all critical documents and control changes effortlessly, enabling faster FDA- and ISO-compliant approvals.
✓ Device Master Records (DMR)
Centrally manage all device data with full history and controlled access rights
✓ Design History File (DHF) Document design changes comprehensively with automated review and approval processes
✓ Regulatory Management and Process Control Manage development according to regulatory requirements to ensure complete documentation and accelerate approvals
✓ PDM Integration
Direct connection to CAD and PDM systems for automatic synchronization of engineering data and bills of materials
✓ Additional capabilities: Integration with EUDAMED/GUDID (coming soon)
Supplier Management
Qualified suppliers for reliable compliance: targeted qualification, continuous evaluation, and compliance-driven monitoring of all suppliers ensure full traceability and audit readiness according to ISO 13485 and GMP.
✓ Supplier Qualification
Onboard and approve suppliers based on audit documentation, compliance criteria, and product-specific risk classifications
✓ Supplier Evaluation
Continuously monitor supplier performance against defined quality and compliance criteria using automated scoring models
✓ Engineering Change Management
Schedule and manage supplier-related changes in real time based on available resources
✓ Resource Planning
Ensure timely material availability according to project and production needs
✓ Preliminary and Actual Costing
Continuously compare budgeted versus actual costs to secure margins
Quality Management
Ensure consistent quality from incoming goods to product release: systematic inspections, traceable error handling, and trained personnel guarantee full compliance with ISO 13485 and FDA requirements.
✓ Quality Inspections in the Value Creation Process
Digital inspection plans from goods receipt to delivery with real-time data capture
✓ CAPA management
Plan corrective and preventive measures in advance, monitor them and check their effectiveness
✓ Complaints Management
Handle customer complaints with root-cause analysis and link them directly to corrective actions
✓ Audit Management
Plan, execute, and document internal and external audits with automated reminders and complete evidence for certification purposes
✓ Traceability
Centrally manage employee certifications and training, ensuring audit-ready documentation is always available
Production Management
Dynamic material planning eliminates bottlenecks—even with high product variant complexity. Electronics-specific functions for PCB assembly and variant management ensure on-time delivery, even with short lead times and fluctuating demand.
✓ Batch and Serial Number Management (DHR)
Document all production steps in the Device History Record for full traceability and easy recalls
✓ManufacturingExecution System (MES)
Monitor production in real time with automatic deviation alerts and direct feedback to quality systems
✓ PDA/MDC with Qualification Management
Automatically verify that only qualified personnel and validated equipment are authorized for production
✓ Label printing (UDI)
Print compliant labels with UDI and expiration dates directly from master data
✓ Compliance with Material Regulations (RoHS, REACH, WEEE)
Manage and demonstrate material labeling according to legal requirements
Service
Ensure compliant aftermarket support across the entire product lifecycle: manage maintenance, repairs, and returns for fast service, sustained product reliability, and patient safety.
✓ Product/Device File
Document all production steps in the Device History Record for full traceability and easy recalls
✓ Manufacturing Execution System (MES)
Enable mobile service operations with real-time access to all relevant data
✓ Maintenance
Plan preventive and reactive measures with qualification checks and audit-ready documentation
✓ Returns
Handle product returns with error analysis and direct integration into complaint and
✓ Complaints Management
Recondition returned devices in compliance with regulations, with full traceability of original and replacement parts.
✓ Additional capabilities: Spare parts management and service contracts
Built-in compliance ensures end-to-end coverage of ISO 13485, FDA 21 CFR Part 11, and EU MDR requirements, providing audit-ready processes, complete documentation, and full traceability without extra administrative effort.
✓ Audit Trail
Tamper-proof recording of all system changes, user activities, and data modifications
✓ Electronic Signature
Digital signatures in accordance with CFR and ISO standards for critical processes, fully digital and without media breaks
✓ Distributor Integration
Automatic access to current market prices, stock levels, and supplier terms
✓ Integrated DMS
Central management of technical documents, SOPs, and production data
✓ Workflow-Supported Control
Automated approval chains and compliance-driven processes across quality management and production
Regulated product development from the first concept to market release: centrally manage all critical documents and control changes effortlessly, enabling faster FDA- and ISO-compliant approvals.
✓ Device Master Records (DMR)
Centrally manage all device data with full history and controlled access rights
✓ Design History File (DHF) Document design changes comprehensively with automated review and approval processes
✓ Regulatory Management and Process Control Manage development according to regulatory requirements to ensure complete documentation and accelerate approvals
✓ PDM Integration
Direct connection to CAD and PDM systems for automatic synchronization of engineering data and bills of materials
✓ Additional capabilities: Integration with EUDAMED/GUDID (coming soon)
Qualified suppliers for reliable compliance: targeted qualification, continuous evaluation, and compliance-driven monitoring of all suppliers ensure full traceability and audit readiness according to ISO 13485 and GMP.
✓ Supplier Qualification
Onboard and approve suppliers based on audit documentation, compliance criteria, and product-specific risk classifications
✓ Supplier Evaluation
Continuously monitor supplier performance against defined quality and compliance criteria using automated scoring models
✓ Engineering Change Management
Schedule and manage supplier-related changes in real time based on available resources
✓ Resource Planning
Ensure timely material availability according to project and production needs
✓ Preliminary and Actual Costing
Continuously compare budgeted versus actual costs to secure margins
Ensure consistent quality from incoming goods to product release: systematic inspections, traceable error handling, and trained personnel guarantee full compliance with ISO 13485 and FDA requirements.
✓ Quality Inspections in the Value Creation Process
Digital inspection plans from goods receipt to delivery with real-time data capture
✓ CAPA management
Plan corrective and preventive measures in advance, monitor them and check their effectiveness
✓ Complaints Management
Handle customer complaints with root-cause analysis and link them directly to corrective actions
✓ Audit Management
Plan, execute, and document internal and external audits with automated reminders and complete evidence for certification purposes
✓ Traceability
Centrally manage employee certifications and training, ensuring audit-ready documentation is always available
Dynamic material planning eliminates bottlenecks—even with high product variant complexity. Electronics-specific functions for PCB assembly and variant management ensure on-time delivery, even with short lead times and fluctuating demand.
✓ Batch and Serial Number Management (DHR)
Document all production steps in the Device History Record for full traceability and easy recalls
✓ManufacturingExecution System (MES)
Monitor production in real time with automatic deviation alerts and direct feedback to quality systems
✓ PDA/MDC with Qualification Management
Automatically verify that only qualified personnel and validated equipment are authorized for production
✓ Label printing (UDI)
Print compliant labels with UDI and expiration dates directly from master data
✓ Compliance with Material Regulations (RoHS, REACH, WEEE)
Manage and demonstrate material labeling according to legal requirements
Ensure compliant aftermarket support across the entire product lifecycle: manage maintenance, repairs, and returns for fast service, sustained product reliability, and patient safety.
✓ Product/Device File
Document all production steps in the Device History Record for full traceability and easy recalls
✓ Manufacturing Execution System (MES)
Enable mobile service operations with real-time access to all relevant data
✓ Maintenance
Plan preventive and reactive measures with qualification checks and audit-ready documentation
✓ Returns
Handle product returns with error analysis and direct integration into complaint and
✓ Complaints Management
Recondition returned devices in compliance with regulations, with full traceability of original and replacement parts.
✓ Additional capabilities: Spare parts management and service contracts
Planning to implement or expand one of our solutions? With over 35 years of ERP experience, Michael Ludes is your ideal point of contact for all questions about our product portfolio.
MICHAEL LUDES
Vice President Presales Proalpha
