Software development for laboratories and medical facilities requires the utmost sensitivity for the safety and quality of the data. That is why we base our work strictly on the applicable norms and industry standards. So we can ensure smooth processes and low error rates.
Certified & reliable
Quality management is particularly important to us. This is why at BECOM we work according to the following standards (certified according to ISO 13485 and 9001):
- ISO 13485 - recognised quality management standard for the design and manufacture of medical products
- ISO 62304 - globally recognised standard for software development in medical sectors
- ISO 9001 - the most important standard worldwide for quality management systems
Step by step to success
BECOM develops its software solutions tailored to your requirements - step by step, using a standardised workflow that has been established over the course of years. However, in doing so we always keep an eye on the big picture: making your everyday work easier.
1. Problem analysis
Together with you, we determine your specific software requirements (specification) - with the aid of our many years of experience. On the basis of this, we discuss the technical implementation, prepare risk assessments and develop a specifications document (specification), which forms the basis of the contract.
2. Project planning
This is followed by specific planning documents that more accurately define the development process. What tools are used? What are the responsibilities? What third-party software is used? In addition to this, we define the architecture of the software.
Then it’s time to implement it. During programming, we already reduce the program code’s susceptibility to errors according to the dual control principle and using automated tests. This creates a solid foundation that later requires fewer correction loops.
On the basis of a verification plan, we test all of the specified features to ensure that they are present and function correctly. We fix critical errors on an ad hoc basis. As soon as verification is completed (i.e. at most, only acceptable errors remain as defined in the risk assessment), the software goes into the second round of testing, namely validation. Here we check the full functionality of the program from the user's point of view in specific use cases.
The product is "finished" and works according to your requirements. Then comes the most time-consuming phase, registration/approval and CE marking. Here, we support you with all product-related documents required for this. This is done in close cooperation with you to ensure quick responses to inquiries from authorities or notified bodies.
After completing validation, we support our customers in the implementation of the software and ongoing operation with instruction documents, training and our support hotline. The procedure in the case of patient-critical errors is also set out – right up to reporting to the authorities.