seleon GmbH
seleon GmbH is one of Central Europe's leading partners for medical technology companies. Focusing on development, production and consulting, we develop tailor-made solutions throughout the entire product life cycle. Our innovative strength and technological expertise create sustainable added value for national and international customers.
The Heilbronn-based company supports medical technology companies of all sizes with their active and non-active medical devices, in vitro diagnostics and drug-device combination products, offering solutions tailored to customer requirements. Our range of services includes:
- Concept workshops in the early stages of product development on product definition, market access, clinical and regulatory strategy, and reimbursement issues
- Development of medical devices, medical software and medical apps, including mechanics, design, system development, electronics, firmware and software
- Regulatory affairs: creation and maintenance of technical documentation and support with international approvals
- Clinical affairs: preparation of clinical evaluations and conduct of clinical trials
- Consulting in quality and process management
- Planning and implementation of production transfers for internally or externally developed medical devices
- Support during production ramp-up and in series production
- Strategic support for market placement, reimbursement issues and market entry
- Change management and product maintenance
- Supplier and discontinuation management