Development of a sustainable solution for regulatory documentation

Efficient and Reliable Development through Model-based Systems Engineering
With more than 16,000 employees, Dräger produces medical and safety technology products for over 190 countries. The fifth-generation family business is now a globally listed company whose technology is used in hospitals, fire departments, rescue services, public authorities, mining and industry.
Dräger is known worldwide for its innovative and reliable solutions in medical and safety technology. However, depending on the location, approval authorities have different requirements for the documentation of architectural decisions for medical devices, particularly with regard to functional safety. This also applies to existing product lines that are being expanded with new features. In order to meet these increasing regulatory requirements, Dräger has taken on the development of a sustainable solution for regulatory documentation in a joint project with UNITY.
The core of this solution, in this case for a patient monitor system, is a consistent MBSE model (Model-Based Systems Engineering), which is used to efficiently generate architectural views. By modeling the system in SysML, design decisions and changes as well as complex links between requirements and architectural elements can be more easily understood in the future. This transparency facilitates documentation and creates a stable basis for future product developments.
A pilot project, which was implemented together with UNITY, is proving successful: using an RFLP-based methodology (Requirements, Functional, Logical, Physical) specially adapted for medical technology, relevant aspects of the safety analysis could be precisely modeled and easily exported. This has considerably improved communication between the departments involved and external partners, increased the traceability of design decisions and significantly increased the overall efficiency of documentation creation.
15 % increased efficiency in creation of architecture documentation in the development process
50 % saving time in establishing the architecture model
Increased transparency through more precise communication
“UNITY AG’s implementation expertise was the key to success. The consultants involved are characterized by a high level of competence, vision, extensive experience and remarkable team spirit. Their structured approach and their ability to develop innovative solutions contributed significantly to the success of the project.”

Dirk Gabriel
VP R&D Patient Monitoring Systems
Your Contacts

Dr.-Ing. Tobias Wigger
Senior Manager

Michael Wolf
Partner, Business Area Lead