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March 2010 - Even before the IEC 62304 harmonisation and the requirements of the FDA, the development of software for medical devices was already subject to strict prerequisites defined in the applicable guidance. Previously these strict regulations were not mandatory for all software components in medical devices, but this changed with a recent amendment to the Medical Devices Act (MPG): since March 2010, each piece of software in medical devices has to be validated in the same way as a medical device in its own right. As a result of the harmonisation of the IEC 62304 standard, it is now a requirement that as well as a defined development process, it is also necessary to follow exact rules for verification and validation. The purpose of this is to prevent defects in the software whenever possible, and to be able to recognise and correct such defects during the development process or during testing. |
