Medical Software - ISO 13485 and IEC 62304 as Part of the Development Process
The importance of software in connection with electrically powered medical devices or as an independent product has grown significantly. The change has caused that more and more often the assessment of the patient's condition and the decision to treat or not to treat is based on the results calculated by the software. The increase in the use of software has also led to adverse effects.
The use of software in medical devices obliges the manufacturer to demonstrate that the software is safe, compliant and high-performance. There are also requirements for the software development, usability and risk management process used to design the product.
Software-based medical devices are subject to the requirements of both quality management and the software lifecycle model, but it has been difficult to build an overall picture of their combination. Come and hear how ISO 13485, IEC 62304 and ISO 14971 are aimed at being tied together. The aim of the seminar is to give the participants an overall picture of the development process of medical software and how the requirements of ISO 13485 and IEC 62304 affect the design process when working in an MDR environment.
Training is conducted in Finnish.