Full-Service in all steps
From the idea to market success
As a full-service group of companies, we provide comprehensive support to manufacturers of medical technology in realizing their products: from the idea phase, through development, the integration of our technologies and components, to approval and series production as well as life cycle management and after sales service.
One-Stop-Shop
Our Services
Consulting
- Regulatory & Clinical Affairs
- Product Lifecycle Management / Quality Management
- Medical Software and Digitization
- Assumption of regulatory roles
- Approval Consulting and Market Introduction
- MDR/IVDR Certification and EU Approval
- Market Surveillance and Device Monitoring
- Development Consulting and Design Transfer Consulting
Development
- Feasibility Studies and Proof of Concept Development
- Technical / Development Consulting
- Flow / Fluidic and Optic Simulations
- Prototype Device and components concepts
- Requirements Engineering / System Architecture Design
- Device Development
- Ongoing Risk Management
- Usability Planning
- Testing & Verification According to Normative Requirement.
Industrialization
- Design to cost
- Design to manufacturing
- Design to Quality
- Design for supply chain
- Wireless Solutions
- Technical assessment
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
Production
- Rapid new product introduction / Ramp up management
- Phase-out management
- Assembly
- Testing
- Review and Optimization of All Relevant Data (DHF)
- Conducting a Process FMEA
- Value Stream Analysis and Lean Concepts
Lifecycle
- Product Return Analysis
- Complaint Management
- Repair Services
- Obsolescences management / consulting
- Change engineering & documentation
- Lifecycle Management
Realize your products with our services, technologies and components.
Consulting
- Regulatory & Clinical Affairs
- Product Lifecycle Management / Quality Management
- Medical Software and Digitization
- Assumption of regulatory roles
- Approval Consulting and Market Introduction
- MDR/IVDR Certification and EU Approval
- Market Surveillance and Device Monitoring
- Development Consulting and Design Transfer Consulting
Development
- Feasibility Studies and Proof of Concept Development
- Technical / Development Consulting
- Flow / Fluidic and Optic Simulations
- Prototype Device and components concepts
- Requirements Engineering / System Architecture Design
- Device Development
- Ongoing Risk Management
- Usability Planning
- Testing & Verification According to Normative Requirement.
Industrialization
- Design to cost
- Design to manufacturing
- Design to Quality
- Design for supply chain
- Wireless Solutions
- Technical assessment
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
Production
- Rapid new product introduction / Ramp up management
- Phase-out management
- Assembly
- Testing
- Review and Optimization of All Relevant Data (DHF)
- Conducting a Process FMEA
- Value Stream Analysis and Lean Concepts
Lifecycle
- Product Return Analysis
- Complaint Management
- Repair Services
- Obsolescences management / consulting
- Change engineering & documentation
- Lifecycle Management.
Our Expertise
Markets & References
We are the partner for the realization of systems in medical technology, especially for
Diagnostic Imaging | In-vitro-Diagnostic | Dental | Surgery | Analysis & Laboratory Technology | Intensive Care
Medical Technology
In-vitro-Diagnostic
Laboratory Technology
Cooperation Partners
Together with our cooperation partners we shape the future.
Cooperation Partners
Together with our cooperation partners we shape the future.
We are the
ai6 SOLUTIONS Group
1,200+
Realized Customer Systems
200+
Employees
5,500 m²
Production Area
166+
Years of Experience
ai6 SOLUTIONS Group
Companies
With its subsidiaries, the ai6 SOLUTIONS Group offers the expertise, capacities and technologies that successfully support medical technology manufacturers.
Seleon GmbH
seleon GmbH has been a leading service partner for medical technology companies in Central Europe for 26 years, focusing on development, consulting, and production. Based on a strong innovative capacity and technological expertise, we develop first-class medical technology products, providing sustainable added value for our national and international customers.
www.seleon.com/en/
