Requirement management
Software development in the field of medical technology products and digital solutions in the healthcare sector ranges between your individual requirements and strict legal requirements. Agile requirement management is needed to meet both conditions.
Our requirements engineers are faced with the constant challenge of keeping an eye on the changing, specific requirements of our customers and complying with the IEC 62304 standard at the same time. This is because the complete documentation of software requirements in accordance with IEC 62304 and QSR (in the USA) is also required by law.
Software architecture
What quality features are essential for a software solution? How can these be implemented effectively? And where are the potential risks hidden?
The architecture of a software not only provides the structure, but is also the key to answering these questions. Experience is therefore a decisive factor in being able to design the software architecture at a higher level of abstraction.
Only the most qualified employees at BAYOOMED are entrusted with the role of software architect. In accordance with the IEC 62304 standard, they develop effective solutions for clients in the medical and pharmaceutical sectors.
This is how we proceed:
phase 1
At the start of a project, we create a system architecture (architectural design) based on the specific requirements of our customers.
The next step consists of identifying potential risks and adding measures to minimize them: For example, a tight schedule, conflicting requirements, ambiguity or a lack of documentation from third-party systems.
phase 2
Now comes the software design, i.e. the clarification of the “how”. Again, we use an analytical approach and initially create a rough draft, which we then develop into a detailed design.
This approach allows us to go into detail without losing sight of the project. For the design itself, we rely on tried-and-tested design principles and patterns.
phase 3
During the implementation phase, we always monitor whether the implementation corresponds to the architecture or whether it needs to be adapted. We are therefore constantly evaluating the architecture, for example using the “Architecture Tradeoff Analysis Method”.
We flexibly integrate the check for changed requirements that make it necessary to adapt the architecture (requirements analysis).
In development cycles, the project goes through several phases that are subject to detailed planning. In order to integrate the specific requirements into the software architecture, it is necessary to analyze the possible effects on the architecture, implementation, schedule and risks. This happens alongside the agile development of the software solution.
In development cycles, the project goes through several phases that are subject to detailed planning. In order to integrate the specific requirements into the software architecture, it is necessary to analyze the possible effects on the architecture, implementation, schedule and risks. This happens alongside the agile development of the software solution.
Proof of Concept
Target-oriented and practical planning
Architecture Design
Efficient implementation of the requirements
Permanent modifiability, maintainability, security and performance
Agile software engineering
The implementation phase of a medical software deals with the concretization and realization of the requirements. The end result is a finished medical or healthcare application that successfully supports your business. Our developers are masters of their tools, have tried and tested methods and are highly proficient in languages.
Whether it’s C#, Java, HTML5, C/C++, JavaScript, MAUI, React Native, or Flutter: We find the right language and framework for every product.
Verification and validation
Automated tests help our developers to ensure the safe and error-free functionality of every new piece of medical software.
In order to provide direct feedback, we monitor all areas of the work from the outset. This allows us to identify weak points at an early stage and invest the time saved in meeting the project deadline.
We support you from the very beginning and work with all stakeholders and user groups to define the requirements for your medical device. These requirements are then further specified by our cross-functional teams, which include requirements engineers, experts in software architecture and verification, and subject matter experts.
The resulting system and software requirements provide the ideal starting point for developing the product in compliance with standards.
Or are you looking for someone to work on your systems? We’d be happy to put your systems through their paces as part of a verification process or to validate your software, infrastructure, and tools.
From requirements management to validation
We’ll be with you every step of the way, working with all stakeholders and user groups to define the requirements for your medical device. These requirements are then further specified by our cross-functional teams, which include requirements engineers, experts in software architecture and verification, and subject matter experts.
The resulting system and software requirements provide the ideal starting point for developing the product in compliance with standards.
Or are you looking for someone to work on your systems? We would be happy to put your systems through their paces as part of a verification process or to validate your software, infrastructure, and tools.