Legacy-Software Softwareentwicklung

Software for Medical Devices

We establish a dialogue with our customers to attain an in-depth understanding of the application in question. This enables us to develop safe, high-quality software that »breathes life« into your ideas.

We establish a dialogue with our customers to attain an in-depth understanding of the application in question. This enables us to develop safe, high-quality software that »breathes life« into your ideas.

Legacy-Software Medizinprodukt Dienstleister

Our Services

We are your partner for innovation

We value our interdisciplinary cooperation with electronics engineers, design engineers, clinicians and all other project participants. Working together, we reach the project goal. We provide the following to help make this happen:

Expertise and experience. There are few companies who can equal our range of experience and specialist competencies. CODIALIST is home to software experts with several years of experience in high-risk facets of medical technology and its associated regulatory demands.

We know what we're talking about. CODIALIST is not a startup. On the contrary: we've spent years building software for complex medical devices and have already passed through all critical learning curves.

Profound understanding. We have long-standing experience in the development of products for medical devices, which means we're used to getting to grips with a project, understanding the clinical application and working with all project participants on an equal footing.

Turnkey development. We produce turnkey software components for medical devices and take care of all the steps required to get there: from compiling and analyzing your requirements to conducting verification and obtaining CE certification/FDA approval. We carry out the verification required to attain such certification and approval. The components we produce can include embedded software, complex control and diagnostic algorithms and graphical user interfaces. Qualified, state-of-the-art tools with a high degree of automation enable us to verify your software and software changes in a short time.

Sustaining engineering. We carry out verification (documentation, tests) for your legacy software to ensure that it complies with current standards. Among other things, we can ensure conformity with IEC 62304 so that the general safety and performance requirements of the MDR or the IVDR are achieved.

Software Medizingeräte Zertifizierung


  • Medical device software development across all safety classes (A to C pursuant to IEC 62304 / Minor to Major level of concern according to the FDA SW guidance)
  • Embedded systems programming in C, integration as part of development
  • Control and diagnostic algorithms and signal processing for embedded systems (Matlab, Simulink)
  • GUI programming (C++)
  • Automated software testing, e.g. hardware-in-the-loop tests, unit tests on the target platform, tool and test bench qualification
  • Software project management – we can integrate ourselves into V-Model projects or work in an agile fashion as required.
  • Documentation and verification in line with IEC 62304 (Medical Device Software)
  • Software requirements and test engineering
  • Software risk management (functional safety and cybersecurity)
  • Software lifecycle management (update concept, security)
  • Legacy software documentation and verification for all target markets

What We Offer

Development in accordance with the international state-of-the-art

Risk management
  • ISO 14971 MedDev Risk Management
  • AAMI TIR32 MedDev Software Risk Management
  • AAMI TIR57 MedDev Security
  • FDA: Cybersecurity In MedDev
Basic safety
  • IEC 60601-1-1 PEMS
  • IEC 60601-1-8 Alarm Systems
  • IEC 60601-1-10 Physiologic closed-loop controllers
  • IEC 62366 Usability Engineering
Quality management
  • ISO 13485 MedDev Quality Management System
Medical device software
  • IEC 62304 Medical Device Software
  • IEC 82304 Health Software
  • FDA Guidance
    • Software Contained in MedDev
    • Software Validation
    • Off-The-Shelf Software