Design Control
Software Quality Assurance
Consult and service - from the idea to the approval
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Services in the area of Software Quality Assurance
In Software Quality Assurance we offer among other things
- Definition of important quality characteristics
- Support for Software Development Plans, Software Life Cycle Plans and Verification Plans
- Support of reviews
- Specification of the right test levels (e.g. in a software system test, integration/regression test or unit test)
- Support in the creation of clearly defined software and system architecture
- Creation and verification of requirements and test cases in compliance with traceability requirements.
- Verification and testing of software
- Provision of testers, test managers, verification managers, requirements engineers
- Customized development of lectures
- Execution of trainings and workshops (e.g. requirements engineering workshop)
qtec as your partner
The major market leaders in Medical Devices in Germany rely on the expertise of qtec. But even start-up companies that have never launched a Medical Device on the market before, are well-advised to use qtec. Our experts cover all aspects from the conceptual phase to the approval of the finished Medical Device by an authority. This is especially true in the field of Software Quality Assurance. Software that has passed through our hands can be approved worldwide. We will support you in the development of:
- Apps
- Medical Devices with software
- Medical Software Systems
Your software processes slow down the entire product development process and are unpopular with your employees and are not lived?
We are able help you to implement the requirements of IEC 62304 and together with you implement clean, lean processes around software that are accepted by your employees.
Software Life Cycle Processes
What makes qtec special in the area of Software Quality Assurance?
Torsten Hertz, Senior Consultant Software Quality & System Architect at qtec:
"This industry is known for its worker's ability to think critically as well as get their hands dirty. With this competence and manpower available, I think we are capable of solving any competence and or capacity problem. In the area of Software Quality Assurance, this means that, in addition to our experts, we also provide software testers for strategic issues, which, for example, can help overcome resource constraints.
Our employees are highly qualified, very experienced, and renowned. My main focus and experience revolve around the systemic interdisciplinary view of the domains software, hardware and mechanics. Throughout my entire professional career (28 years) and to this day, I have remained closely associated with medical technology. From my roots in a degree course in computer engineering, I quickly moved into the professional areas of software development and software quality assurance, as well as project and development management. For many years, I have been working as a consultant in the development and approval of medical devices (including numerous Class IIb products). This also includes giving technical presentations, for example at MedConf and TdSE. The seamless connection between product specifications and system architecture is a qtec credo in the context of design controls. This credo is close to my heart and I like to represent and convey it as an expert in customer projects -as well as in qtec academy seminars.
Another qtec strength is that we are always able to integrate solutions into the customer's specific environment. This is also because our employees have gotten to know a great number of companies and their way of working. The qtec experts also have immense knowledge of the regulatory requirements. The customer does not receive a standard solution, instead, they receive one that fits into their company".
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