Full-Service in all steps
From the idea to market success
One-Stop-Shop
Our Services
- 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
- 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.
- Design to cost
- Design to manufacturing
- Design to Quality
- Design for supply chain
- Wireless Solutions
- Technical assessment
- 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
- 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
- Product Return Analysis
- Complaint Management
- Repair Services
- Obsolescences management / consulting
- Change engineering & documentation
- Lifecycle Management
- 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
- 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.
- Design to cost
- Design to manufacturing
- Design to Quality
- Design for supply chain
- Wireless Solutions
- Technical assessment
- 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
- 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
- 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
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
ai6 SOLUTIONS Group
Companies
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/
LM4med offers a “Legal Manufacturer as a Service” solution, ensuring compliant product introductions to the European market under MDR and IVDR. Acting as the manufacturer for your product, without being involved in its production or development, all regulatory requirements are met. This allows you to focus on your core competencies while all legal and regulatory obligations for the EU market, including communication with Notified Bodies and authorities, are managed. www.lm4med.com/en/
