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

The CODIALISTS

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--labyrinth

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.

icon shield

Software components in all safety classes

From non-critical to life-sustaining - and always risk-based and transparent: we produce software components in all safety classes.

icon sheet-stack

Every implementation is carried out on a »ready-to-approve« basis

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

»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

References

Softwareentwicklung Medizingerät 62304

EXCOR® Active

EXCOR® Active is a mobile drive system for artificial hearts. It is predominantly used with children. The software developed by the CODIALISTS controls and monitors the system and enables its intuitive use.
Learn more
Legacy-Software Medizingerät MDR

Ikus® User Interface

EXCOR® Pediatric is a mechanic, pulsatile ventricular assist system for patients with terminal heart insufficiency. The »Ikus« drive unit is designed for the inpatient care of such patients. 
Learn more