ai6 Solutions GmbH

Von der Idee bis zum Markterfolg & von der Komponente bis zum Komplettsystem.

Als Full-Service-Unternehmensgruppe unterstützen wir Hersteller aus der Medizintechnik ganzheitlich bei der Realisierung ihrer Produkte: Von der Ideenphase, über die Entwicklung, durch die Integration unserer Technologien & Komponenten, bis hin zur Zulassung und Serienproduktion sowie dem Lifecycle Management und After Sales Service.

1. Consulting
Regulatory & Clinical Affairs
Product Lifecycle Management / Quality Management
Medical Software
Digitization
Assumption of regulatory roles
Approval Consulting and Market Introduction
MDR/IVDR Certification and EU Approval
Market Surveillance and Device Monitoring
Development and Design Transfer Consulting

2. Development
Feasibility Studies / Proof of Concept Development
Technical Consulting and Prototype Concepts
Flow / Fluidic and Optic Simulations
Prototype Design and Development
Requirements Engineering and System Architecture Design
Device Development
Ongoing Risk Management
Usability Planning
Testing & Verification According to Normative Requirements

3. Industrialization
Design to cost
Design to manufacturing
Design to Quality
Design for supply chain
Wireless Solutions
Technical assessment

4. Supply Chain
Global sourcing und disposition strategies
Supplier Qualification
Supplier management
Contract negotiation & management
Supply chain resilience
Supply Chain Management
Tracking and Tracing
Development of Sourcing Strategies Including Second-Source Development

5. Production
Rapid new product introduction and Ramp up management
Phase-out management
Tracking and Tracing
Assembly
Testing
Review and Optimization of All Relevant Data (DHF)
Conducting a Process FMEA
Value Stream Analysis and Lean Concepts

6. Lifecycle
Product Return Analysis
Complaint Management
Repair Services
Obsolescences management / consulting
Change engineering & documentation
Lifecycle Management