CONSULTING - Regulatory Affairs

seleon GmbH

Heilbronn, Germany

seleon gmbh has been one of the leading development, consulting and production service providers in medical technology for over 20 years. We support start-ups, small and medium-sized companies as well as corporations with their active and non-active medical devices, in-vitro diagnostics and drug-device combination products. In our One Stop Shop we offer you solutions tailored to your requirements already in the discovery phase concept workshops on product definition, market access, clinical regulatory strategy and reimbursement 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 conduct of clinical trials, in quality and process management, in the production transfer of medical products developed by you, us or third parties, during ramp-up and series production for market placement and reimbursement issues and in change management and product maintenance. You can find further information on our website www.seleon.de. We regularly publish interesting knowledge-based articles on current regulatory topics free of charge on our second website www.regulatory-affairs.org.