Quality Management

Quality Management

Software Life Cycle Processes

Processes for the life cycle of Medical Device Software

We help you with the implementation from the standardized WHAT into the normal HOW.

Software Life Cycle according to IEC 62304

According to the standard, the life cycle of software consists of:

  • Software development
  • Software Maintenance
  • Software Risk Management
  • Software Configuration Management
  • Problem solution for software

The international standard IEC 62304, and the european standard EN ISO 62304, places requirements on the life cycle processes of software that is either:

  • a part of a Medical Device (embedded)
  • or independent software (stand-alone / Software as a Medical Device (SaMD)).

The focus of IEC 62304 is the development of software without specifying a particular sequence or process model. Instead, requirements are placed on individual steps within the development process, e.g. documentation of software requirements and architecture.

Software Life Cycle Processes

Processes for the Life Cycle of Medical Device Software

We help you with the implementation from the standardized what into the normal how.

Software Life Cycle according to IEC 62304

According to the standard, the Life Cycle of Software consists of:

  • Software development
  • Software Maintenance
  • Software Risk Management
  • Software Configuration Management
  • Problem solution for software

The international standard IEC 62304 and EN 62304, which is standardized in Europe, places requirements on the life cycle processes of

  • Software that is part of a Medical Device (embedded)
  • or independent software (stand-alone / Software as a Medical device(SaMD)).

The focus of IEC 62304 is the development of software without specifying a particular sequence or process model. Instead, requirements are placed on individual steps within the process, e.g. documentation of software requirements and architecture.

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

Whether your software development is agile or based on the V or waterfall model, we can help to implement the requirements of IEC 62304. Addtionally, we will work with you to establish clean, lean software processes that are accepted by your employees.

For example, we can support you with the following activities:

  • Redefinition of standard requirements into internal processes
  • Translation of internal processes into concrete methods
  • Development of Best Practices according to Medical Spice*
  • Monitoring compliance with all regulatory requirements
  • Creation of indicators to measure project development
  • Support and improvement of agile projects (taking over the role of Scrum Master and Product Owner)

Do you need support in creating software development documentation or in verifying and testing software?
Software Quality Assurance

* Medical SPICE is the guideline VDI 5702 part 1, where SPICE stands for Software Process Improvement and Capability Determination. SPICE defines methods for evaluating the performance of Software development for Medical Devices. The guideline does not impose any additional normative requirements, but attempts to simplify the existing regulations.

What makes qtec special in the area of Software?

Markus Manleitner, Senior Consultant Software Quality & Regulatory at qtec:

"From the normative WHAT to the daily HOW: We help our customers to implement the Software Life Cycle Processes. In doing so, we can take care of the entire product Life Cycle from the idea to the approval. This distinguishes us from many providers who are specialized in sub-areas like verification or agile processes.

Our employees are highly qualified, very experienced and renowned. For example, I have been head of the VDI Technical Committee for Software Quality in Medical Devices for 8 years now and have given talks at 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".

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