seleon GmbH is the leading service partner for medical technology companies in Central Europe with a focus on the areas of development, production and consulting. On the basis of a pronounced innovative strength and technological ambition, seleon develops first-class solutions for its clients and thus represents a sustainable added value for national and international customers.
The Heilbronn-based company supports medical technology companies, regardless of size, with their active and non-active medical devices, in-vitro diagnostics and drug-device combination products and offers solutions tailored to the client’s requirements:
• Concept workshops in the discovery phase for product definition, market access, clinical & regulatory strategy and reimbursement topics.
• in the development of medical devices, medical software and medical apps, with the assumption of all trades (mechanics, design, system, electronics, firmware and software)
• 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 the conduct of clinical trials,
• in quality and process management,
• in the production transfer of medical products developed by the customer, seleon or third parties,
• ramp-up and series production
• market placement and reimbursement issues, as well as
• change management and product maintenance
• supplier and discontinuation management.
In addition to the website www.seleon.de, seleon GmbH regularly publishes interesting, free knowledge articles on current regulatory topics
on the website www.regulatory-affairs.org.