BAYOONET Group

The BAYOONET Group is a German software and IT service provider founded in 2001, headquartered in Darmstadt. The group specializes in developing software solutions for highly regulated environments, including medical technology, pharmaceuticals, and critical infrastructure. They offer services ranging from custom software engineering to regulatory consulting and acting as a legal manufacturer for medical devices and in-vitro diagnostics. Key subsidiaries include BAYOOSOFT GmbH, which focuses on software distribution and access management, and BAYOOCARE, which provides regulatory expertise and clinical support for MedTech companies. The group maintains certifications such as ISO 9001, ISO 13485, and ISO 27001, and is experienced in FDA and EU MDR compliance.