A
We produce radiographic medical devices. They include both embedded software (microcontrollers) and stand-alone software (PACS). I’m involved in the process of quality assurance, we got ISO 13485 certificate 3 years ago. Now it’s time to introduce the requirements of the new standard EN 62304 Medical Device Software.
The question is that there is a difference between entire device risk management and software risk management. We used to apply the extended tables from ISO 14971 and IEC 60601-1 (potential electrical, electromagnetic, mechanical hazards). Nevertheless I can’t find out special literature on software, almost all the materials concentrate on software security. This aspect is very important but it’s just the particular one among many other. Frankly speaking I’d like to view an example of risk management file for the specific programmable device, or a sample potential risk questionnaire stressed on the software. If you can share this example it would be great. If it’s not for free we are ready to discuss the price. Finally if you give a link to the special library it would be very helpful.
The second question is the hazard software risk analysis approach. For example I studied FMEA and FTA, though I don’t know to what extent they are appropriate for software. Please point me to where “dig out”.
Thanks a lot.
The question is that there is a difference between entire device risk management and software risk management. We used to apply the extended tables from ISO 14971 and IEC 60601-1 (potential electrical, electromagnetic, mechanical hazards). Nevertheless I can’t find out special literature on software, almost all the materials concentrate on software security. This aspect is very important but it’s just the particular one among many other. Frankly speaking I’d like to view an example of risk management file for the specific programmable device, or a sample potential risk questionnaire stressed on the software. If you can share this example it would be great. If it’s not for free we are ready to discuss the price. Finally if you give a link to the special library it would be very helpful.
The second question is the hazard software risk analysis approach. For example I studied FMEA and FTA, though I don’t know to what extent they are appropriate for software. Please point me to where “dig out”.
Thanks a lot.