Full-Service in allen Schritten
Von der Idee bis zum Markterfolg &
von der Komponente bis zum Komplettsystem
Alles aus einer Hand
Unsere Leistungen
- 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
- 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
- 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 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.
- 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
- 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
- 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
- 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 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.
- Product Return Analysis
- Complaint Management
- Repair Services
- Obsolescences management / consulting
- Change engineering & documentation
- Lifecycle Management.
Unsere Expertise
Märkte & Referenzen
Bildgebende Diagnostik | In-vitro-Diagnostik | Dental | Chirurgie | Analyse- & Labortechnik | Intensive Care
Kooperationspartner
wir die Zukunft und den Fortschritt.
Kooperationspartner
wir die Zukunft und den Fortschritt.
Wir sind die
ai6 SOLUTIONS Gruppe
ai6 SOLUTIONS Gruppe
Unternehmen
Die seleon GmbH ist seit 26 Jahren in Zentraleuropa ein führender Dienstleistungspartner für Medizintechnikunternehmen mit Konzentration auf die Bereiche Entwicklung, Consulting und Produktion. Auf Basis einer ausgeprägten Innovationskraft und des hohen technologischen Anspruchs erarbeitet das Unternehmen erstklassige Medizintechnikprodukte und realisieren damit einen nachhaltigen Mehrwert für ihre nationalen und internationalen Kunden.
www.seleon.com/de/
LM4med bietet als „Legal Manufacturer as a Service“ umfassende Lösungen für die konforme Einführung von Medizinprodukten und In-vitro-Diagnostika in den europäischen Markt gemäß MDR und IVDR. Als rechtlicher Hersteller übernimmt LM4med alle regulatorischen Verpflichtungen, inklusive der Kommunikation mit benannten Stellen und Behörden, während Unternehmen sich auf ihre Kernkompetenzen konzentrieren können.
www.lm4med.com