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.
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?
Torsten Hertz, Senior Consultant Software Quality & System Architect 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. 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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