Softwareentwicklung Medical Device Dienstleister

We Develop Software for Medical Devices

We share our know-how, experience and passion with fellow specialists - specialists who, like us, are dedicated to bringing innovations in medical technology to life. In doing so, we help make lasting improvements to people's lives.

We share our know-how, experience and passion with fellow specialists - specialists who, like us, are dedicated to bringing innovations in medical technology to life. In doing so, we help make lasting improvements to people's lives.

Where we come from

We are the CODIALISTS – a spin-off of Berlin Heart

CODIALIST GmbH was founded by employees of Berlin Heart GmbH at the beginning of 2020. In founding the firm, our goal was to make our extensive, long-standing experience in the development and lifecycle management of medical device software available to other companies and institutions.

Berlin Heart GmbH develops, produces and markets innovative systems for mechanical circulatory support. The systems are implanted in patients of every age and of every size. The EXCOR® Pediatric system, which was specially developed for younger patients, is the only ventricular assist device worldwide with an approval for use on children and young people.

Berlin Heart's globally recognized products make it a market leader in the industry.

 

How We Work

You have ideas, we have the software

We have first-hand experience of the technical hurdles and regulatory challenges involved in the development of innovations

This knowledge enables us to achieve an in-depth understanding of even the most diverse medical devices within a short space of time. Thanks to an agile, pragmatic style of working and many years of experience, we can implement software developments swiftly. In so doing, we become part of your medical innovation.

 

The Management

Softwareentwicklung Medizingerät Dienstleister

Sven-René Friedel

»We breathe life into medical technology.«

Sven-René Friedel is managing director of CODIALIST GmbH. Following his studies in business administration, Sven-René occupied a variety of management roles at Berlin Heart, where he accompanied its progression to globals market leader in the field of pediatric heart and circulatory support. Sven's key interests lie in entrepreneurship and innovation. In his role with the CODIALISTS, he is responsible for the company's commercial development.

»We understand your ideas. Together, we bring your innovations to market.«

Dominik Karch is development manager at CODIALIST GmbH. Dominik studied medical informatics and has a long-standing interest in the ways that using digital technologies can provide benefits to medicine. After obtaining his doctorate from Heidelberg University, Dominik spent a number of years overseeing hardware and software development for medical devices at Berlin Heart GmbH. He helped shape numerous change processes as part of this role and, in doing so, laid the foundations for successful development projects. In his role with the CODIALISTS, he makes sure that all parties involved fully understand the applications and their regulatory requirements so that they develop safe, high-quality software.

Software Medical Device IVDR

Dr. Dominik Karch

Software Medizinprodukt Dienstleister

Heiko Atzpadin

»Often, the challenge is to find the balance between what's necessary and what's possible.«

Heiko Atzpadin After studying electrical engineering in Berlin, Heiko amassed several years' experience as a developer, project manager and department head working on the development of security-critical communication systems. As a project and team leader at Berlin Heart, he was responsible for obtaining CE certification for its EXCOR® Active software and preparing for the approval processes in North America and Japan. In his role with the CODIALISTS, Heiko ensures that the long-standing experience of the entire project team is made available to customers as part of the product development process. Heiko is driven by the goal of strengthening our customers' capacity for innovation with pragmatic, automated solutions.

Our Network Partners

CODIALIST GmbH has a network of trusted partners covering all value-adding elements of medical device development. When issues arise whose scope goes beyond that of medical device software development, CODIALIST is equipped to draw on or procure this expertise.

 

 

Berlin Heart

Berlin Heart GmbH

Hardware development (test benches), regulatory affairs

3R-LifeScience

3R LifeScience GmbH

Interim and project management for product development

Zollner

Zollner Elektronik AG

Development and production of mechatronic systems

We work alongside selected partners to manage hardware projects from start to finish: from organisation and planning to delivery and complete implementation.