sepp.med GmbH

sepp.med Quality ensures success: development, integration and quality assurance .

sepp.med gmbh - We make digitalization, but secure! 

sepp.med is a medium-sized, owner-managed company that specializes in smart IT solutions and quality assurance in complex, safety-critical areas. We are shaping the digitalization of the future with and for our customers. For over 40 years, we have been implementing innovative projects in the field of agile software development, quality assurance and testing in the medical technology, pharmaceutical, automotive, avionics, public sector and finance & assurance industries.

• Requirements definition and management
• Risk management
• Software/system development
• Architecture and design
• Integration
• Test design & Management
• Test automation and model-based testing
• IT security and software security
• Medical IT due diligence 
• Consulting in accordance with regulatory requirements
• Compliance assurance for internationally recognized norms and standards (includingincluding IEC 62304, ISO 14971, ISO 13485, GAMP 5, FDA 21 CFR 820, FDA 21 CFR 11)
• Process optimization and validation & CSV
• Training and certification according to ISTQB®, ASQF®, IREB® and iSQI standards

• Software as a medical device
• model-based testing (mbtsuite.com)
• agile and standards-compliant software development and testing
• regulatory consulting
• algorithms
• AI in MedTech