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Quality Management
and Work Process


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Algorithm Design and Product Development

Chimaera has many years of experience in algorithm design and product development. Therefore, we can provide a wide range of medical image processing expertise to your company. The cooperation with our global customers is based on confidence, teamwork, responsibility and skills. Thereby, it is possible for us to achieve the desired result.

Quality assessment

Constant quality assessment during the development and integration of the customer into the develoment process.


We integrate our software solutions seamlessly into your application on different platforms.

Academic background

All our employees have a strong background in the field of medical image processing.

Quality Management

In the targeted markets for highly innovative medical and industrial software, only products of high quality, robustness, and good usability yield a broad acceptance among customers. Therefore, we attribute great importance for all developments made within our company. Quality is not just an empty phrase for us, but a key component in our company. 

Therefore, we establish and maintain an integrated quality and process management system consistently within the entire company. All developments run through various cycles with different quality management steps, such that the results are guaranteed to be safe and reliable. In addition, each product undergoes various testing and evaluation stages before final approval. Quality routines are created that ensure the continuous improvement of our processes and the resulting products and services.

Our success in good quality management practices is reflected by the achieved positive certification results:

Regulatory Compliance Software Development Certified Management System
IEC 62366 Application of usability engineering to medical devices Quality Management (DIN EN ISO 13485)
IEC 62304 Software life cycle processes High quality of our products
DIN EN ISO 14971 Application of risk management to medical devices Regulatory affairs support for our OEM products
DIN EN ISO 13485 Quality management systems Supplier quality assurance agreements (QAA)
FDA 21 CFR 820.50 Purchasing Controls Dashboard server for automatic testing
FDA Traditional Premarket Notification 510(k) Software-Lifecycle-Management (EN62304)
Usability (EN62366) Risk Management (ISO 14971)  
Start of the work process

We start with a kickoff meeting to get know each other. Our team is able to provide all components as single elements for existing solutions or as a complete package.

Requirement Capturing

We are flexible at any time. The work project is customized for your needs similar as our modular and transparent pricing system. You only get what you need.

Offer Creation

We start the project and work with a web-based teamwork platform. Through the customer integration you can work together with us and have an overview about the project status.


We develop the first prototype suitable to the requirements and identification solution opportunities.


We analyze the performance and optimize the algorithms for image processing.

Technology validation

Our team keeps track of the continuously expanding scope of functions and the complexity. The project is orientated to our quality management (DIN EN ISO 13485). At the same, they ensure that the performance and quality of your medical devices continues to increase.

Product development

We own a rich portfolio of service software, which includes simple installation, the ensuring of system quality through documented quality tests and remote diagnostics and maintenance (IEC 62366).


All measures for systematical identification, analysis, evaluation, supervision and control of risks. Establish criteria to place and rate risks (DIN EN ISO 14971).

Risk management

We guarantee for reaching the necessary quality level – always combined with the market requirements of medical engineering.


At the end we offer a customer training without dependency. Of course we consult you after the project if you need anything. Maintenance and possible integration support belongs to our services (IEC 62304).

Lifecycle management

Successful accomplished project