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Fintech
The importance of Performance and Load Testing can’t be overstated in the context of Fintech and Insurtech. Performance testing is the process of verifying systems operation that includes measuring the speed and reliability under varying conditions. Load testing is the process of determining the behavior of the system while multiple users concurrently access it at the same time.
Financial technology (abbreviated Fintech) is the technology and innovation that aims to compete with traditional financial methods in the delivery of financial services. A subset of fintech companies that focus on the insurance industry is collectively abbreviated as Insurtech companies. The trend of utilizing smartphones for mobile banking, investing, insuring, borrowing services, and cryptocurrency is an example of technologies aiming to make financial services more accessible to the public.
It is imperative that the performance of financial software be verified and validated as part of any relevant risk reduction plan, in addition to the traditional quality control and assurance implications of the software performance on the entire business.
Medical Device
The Medical Device industry is known for its emphasis on testing and validating each aspect of every product and technology. This industry rather resembles aviation, autonomic transportation, nuclear plants, and other safety-critical business, where risk management concerns constantly influence the complete product life cycles.
The methods of verification and validation are common and world-wide used in various fields. They must ensure that each device complies with the relevant regulations. Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Validation means confirmation by examination and provision of objective evidence that the requirements for a specific intended use can be consistently fulfilled.
The European MDR specifies in annex II that results of verification and validation are a part of the technical documentation. Every product needs to be verified and validated. Process Validation is defined in the FDA’s 21 CFR 820.75. Design Verification and Validation are also addressed by the FDA's 21 CFR 820.30 and specified more in detail in FDA's Design Control Guidance. ISO 13485 gives regulations on the Design and Development Verification and Validation as well as Process Validation.
Modern medical devices are largely software-oriented products. The FDA guidance recommends that the software development life cycle should be completely integrated in the risk management process according to ISO 14971. Software Verification aims for consistency, completeness and correctness of the software and all parts of documentation. Software Validation confirms that software specifications conform to user needs and the intended use.
All the above specified activities are not only important to meet regulatory requirements, but also for public health and safety and in a further sense also to ensure business success. Therefore, it is essential that these activities are utterly planned, constantly updated and be compatible with general procedures in the company.
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