Design Control

Design Control

Software Quality Assurance

Consult and service - from the idea to the approval

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Software Quality Assurance

Consult and service - from the idea to the approval

01001101 01101001 01110100 00100000 01110001 01110100 01100101 01100011 00100000 01111010 01110101 01101101 00100000 01000101 01110010  01100110 01101111 01101100 01100111 00101110 *

*Binary code according to ASCII

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)

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 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)
 

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

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?

Markus Manleitner, Senior Consultant Software Quality & Regulatory 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, experienced and renowned. For example, I have been head of the VDI Technical Committee for Software Quality in Medical Technology for 8 years now and have given presentations at numerous conferences in Germany, Europe, and China. But I am not only a quality engineer, I originally developed and tested software myself before I came to software quality in the medical environment. In total, I gained more than 20 years of professional experience and I manage the entire software life cycle and its regulatory requirements. This is one of the values qtec provides other companies.

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".