QUALITY MANAGEMENT
Quality in healthcare
OUR COMMITMENT
IT-Choice is certified by TÜV Hessen to DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016.
In addition, our Information Security Management System (ISMS) has been certified by TÜV Rheinland under ISO/IEC 27001:2022.
While DIN EN ISO 9001:2015 focuses on customer satisfaction and the assessment of risks and opportunities, our DIN EN ISO 13485:2016 certification also enables us to develop software as a medical device.
Our ISO/IEC 27001:2022 certification demonstrates that we comply with the highest IT security standards and protect sensitive data through clearly defined, traceable processes.
Consultation and decision-making
Together, we discuss your goals and consider whether your planned software solution needs to be approved as a medical device or whether there are alternative practicable options.
Patient safety
Of course, we focus on the safety and well-being of patients throughout the entire development process. Risk management is carried out in accordance with DIN EN ISO 14971, which defines how hazards to users associated with a medical device can be identified and managed. Software development is based on IEC 62304, which defines the regulatory requirements of the life cycle process for medical software.
Data security
In everything we do, we of course take into account the provisions of the European General Data Protection Regulation and the German Federal Data Protection Act. The necessary planning and measures are supported by our data protection officers.
Information security
With certificationto ISO/IEC 27001:2022, we ensure that sensitive data belonging to our customers and their patients is protected as effectively as possible at all times. Our Information Security Management System (ISMS) defines clear processes for identifying, assessing and managing risks to the confidentiality, integrity and availability of information – from software development and operations through to the continuous improvement of our security measures.
More information on information security at IT-Choice:
AGILE APPROACH
As part of the certification, we succeeded in adapting our Scrum process so that it is 100% compatible with the standard´s requirements. This brings many advantages, benefiting both our customers and our employees.
Scrum is a well-established and efficient approach for implementing projects using agile software development. Scrum’s process model and role definitions are designed to manage even very complex software projects whose requirements may not yet be fully defined at the start of the project.
Further information:
