Devices

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

Competences

Product development, production, regulatory affairs, clinical affairs, quality management

Address

Im Zukunftspark 9
DE-D-74076 Heilbronn

Phone: +49 (0) 7131-2774 0
Fax: +49 (0) 7131-2774 100
E-Mail:
Web: www.seleon.de