seleon GmbH is a German engineering and regulatory consulting service provider specializing in complex medical devices, in vitro diagnostics, and drug-device combination products. Founded in 1998 and headquartered in Heilbronn, the company operates development and manufacturing sites across Germany, including Heilbronn, Dessau-Roßlau, and Leipzig.
The company provides integrated support across product definition, system architecture, hardware and software development, and technical documentation. Its consulting division assists clients with design-level compliance, verification and validation (V&V), and certification strategies targeting CE marking under the EU-MDR/IVDR and FDA market authorization.
Operating under an EN ISO 13485 certified quality management system, seleon combines hands-on engineering capabilities (electronics, mechatronics, and embedded software) with dedicated regulatory and clinical affairs advisory services.