From development to product launch

Our expertise in regulatory affairs ensures that your medical devices comply with the legal standard requirements and thus guarantee safety and efficacy for users. We offer you customized support from development to product launch. With our focus on quality and risk management, we guarantee that your medical devices comply with legal requirements. Our experts have extensive experience in standard-compliant documentation, CE conformity assessment, support for CB type testing and much more when it comes to preparing for approval. We provide you with comprehensive advice and support during the approval process, take care of the design transfer and produce your medical device in series for you.

Contact us today and start your path to the market launch of your medical device!