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.
Specific image processing
Find solutions for highly specific image processing problems an keep the processing fast
Constant quality assessment during development - Integration of customer into the develoment process
Integrate seamlessly into your application on different platforms
Profound and longterm theoretical background in the fields of medical image processing
In the targeted markets for highly innovative medical and industrial software, only products of high quality, robustness, and good usability yield broad acceptance among the 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)|
All Chimaera services start with the original idea followed by the requirements engineering, and continue with the design of the usability and the software architecture.
Our web-based project management system allows a close and efficient teamwork between your company and us. The system provides a ticketing system to manage tasks and issues. A project-based Wiki platform allows to record and share useful information. We can thus provide an overview about the progress of the project anytime. Involved team members of your company and us can easily access the project management system using a standard web browser.
We developed a characteristic project process overview for a better insight into how we work. Each project step can be joint, remote, and single discount depending on your needs.
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.
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.
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.
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.
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).
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).