Software Medizingerät Dienstleister

We Breathe Life into Medical Technology

CODIALIST is the software
development firm for
medical devices. We are
a spin-off of Berlin Heart.

Software Medizingerät IVDR


We develop medical device software for embedded systems

We understand the requirements of customers, users and regulatory institutions.

We provide turnkey software components and take care of all the steps required to get there: from compiling and analyzing your requirements to conducting verification and producing approval documentation for your target markets. In addition, we produce standard-compliant verification for your medical devices legacy software*.
The CODIALISTS represent a wide selection of competencies in programming, algorithms, verification, documentation and control engineering. As such, they are the ideal partner for even highly complex projects.

* Legacy software = Software that has been in use for a long period and that was legally placed on the market at the time of first use, but no longer meets the requirements of the relevant standard(s).

Our experience is the key to your success

icon sheet-stack

Every implementation is carried out on a »ready-for-approval« basis

Our broad regulatory experience enable us to implement requirements for your international target markets - and help you keep your legacy software on the market.

icon V

Relevant project experience for your application

With our background as a manufacturer of complex medical devices, we know the innovation process from the idea to market approval and thus quickly build up an understanding of your application.


Competency in control and diagnostic algorithms

Want to bring complex product ideas to life? Benefit from our know-how in the field of control and diagnostic algorithms.

»We become part of your medical innovation.«
Softwareentwicklung Medizinprodukt FDA

Our Services

We are your partner for innovation

We produce turnkey software components for medical devices and take care of all the steps required to get there: from compiling your requirements to conducting verification and obtaining CE certification/FDA approval. Such components can include embedded software, complex algorithms for the control of devices (medical pumps, stimulation devices and more), diagnostic algorithms and graphical user interfaces. Qualified state-of-the-art tools and a high degree of automation enable us to verify your software and software changes in a short time.

Softwareentwicklung Medizingerät 62304


  • Software components for medical devices
  • Software project management
  • Embedded systems programming in C
  • Control and diagnostic algorithms
  • GUI programming
  • Software requirements and test engineering
  • Software risk management
  • Automated testing
  • Software lifecycle management
  • Legacy software documentation and verification for your target markets

More details