For medical devices that cannot operate without software, it is essential to validate and prove, in accordance with the IEC 62304 standard, that the intended use is fully met and that the device operates safely and accurately for the end user.
For this, evaluating the software used in the medical device within the scope of EN ISO 14971 Standard for the application of risk management to medical devices and documenting and realizing all the steps called Software Development Life Cycle in the processes starting from design to coding and testing will provide great convenience in your validation studies.
In this process, data security, operational and functional features, design, and end-user interface risks are validated to reduce software-related errors, design and environmental function impacts, and potential user errors. The goal is to eliminate parameters that could negatively impact product safety and performance, thereby ensuring the production of safe products for patients.
