sepp.med GmbH

sepp.med – engineering, consulting, AI solutions, and training for regulated markets.

sepp.med supports companies in healthcare, medical technology, and other safety-critical industries in the development, quality assurance, validation, and secure integration of complex software solutions—standards-compliant, efficient, and future-ready.
 

sepp.med is a mid-sized, owner-managed software and consulting company with more than 40 years of experience in safety-critical and regulated markets. Its focus is on software development, quality assurance, regulatory consulting, cybersecurity, and the productive use of artificial intelligence.

For customers in medical technology, healthcare, life science, automotive, industry, fintech, and the public sector, sepp.med supports development projects from the initial idea to tested, release-ready software—with technical excellence, deep standards expertise, and hands-on experience.
 

• AI integration in organizations
• AI-assisted software testing
• Quality assurance for AI systems
• Consulting on the productive use of AI
• Software development for regulated and safety-critical systems
• Software testing, test automation, and quality assurance
• Requirements engineering and application lifecycle management
• Cybersecurity consulting, threat modeling, and NIS2
• Validation and regulatory affairs for MedTech
• MedTech software development per IEC 62304
• Software validation per ISO 13485 and IEC 62304
• Training, workshops, and in-house courses from the sepp.med Academy
   

• AI in MedTech and healthcare
• AI-assisted software development and quality assurance
• Secure AI integration into products, processes, and organizations
• Software as a Medical Device (SaMD)
• IEC 62304, ISO 13485, ISO 14971, MDR, and FDA
• Cybersecurity, NIS2, threat modeling, and secure-by-design
• Agile, standards-compliant software development
• DevOps, CI/CD, test automation, and embedded testing
• Accessibility testing and digital accessibility