seleon GmbH

Seleon GmbH has been one of the leading development, consulting and production service providers in medical technology for 26 years.

As a full service provider, we offer you solutions tailored to your requirements

• right from the discovery phase, concept workshops on product definition, market access, clinical & regulatory strategy, reimbursement and ESG topics
• in the development of medical devices, medical software and medical apps,
• with Regulatory Affairs in the creation and maintenance of technical documentation and international product approvals
• with Clinical Affairs in the preparation of clinical evaluations and conducting clinical trials,
• in quality and process management,
• in the production transfer of medical devices developed by you, by us or by third parties,
• in ramp-up and series production
• in market placement and reimbursement issues as well as
• in change management and product maintenance.

Development:

• Project Management
• System Development
• Electronics
• Software / Firmware
• Mechanics / Mechatronics
• Documentation / Testing
• Lifecycle Management 

Consulting:

• Approval Consulting 
• Regulatory Affairs
• Clinical Research Organization - CRO / Clinical Affairs
• Product Life Cycle Management / Quality Management
• Medical Software
• Digitization
• Taking over regulatory roles
• Start Up Consulting
• Regulatory & IP Due Diligence Services
• Instruction and Training

Production:

• Supply chain management
• Medical technology production
• Special equipment
• Manufacturing and test equipment
• Quality management