What is IEC 62304?

[@daixtr]

El magnifeco! Thank you. So in this SDLC compliance thing, can you give us an example but specific software compliance tool that was used in IEC62304?

[@MedicalDeviceAcademy]

I'm not 100% sure what kind of example you are looking for. In the video, Matthew did not mention the word "tool" and compliance was mentioned 3 times (6:55-7:18). Matthew indicated that compliance with IEC 62304 is demonstrated by inspection of the documentation required by IEC 62304. Specifically, there are 10 documents that the FDA asks companies to attach in a 510(k) and all of those documents are required by IEC 62304 except for the software description document. Another example of how this is done is when NRTL labs request that companies fill out an IEC 62304 checklist to demonstrate where all of the software documentation requirements can be found when you are submitting a device with software to the lab for electrical safety (i.e., IEC 60601-1). In both cases, the inspector is using a checklist that lists each document requirement that is a required output of IEC 62304. Usually, a keyword search can help you find the required documents. For example "and documented" appears 22 times in IEC 62304. Only some of these are required documentation, but that gives you a good list of what will be required (I started a list by starting at the end of the standard...) Clause 5.3.6 Clause 5.4.4 Clause 5.5.5 Clause 5.6.3 Clause 6.2.2 Clause 7.2.1

[@TalisonBrendon]

Thanks bro, I'm doing a project for my college and I need to understand this ISO to apply

[@MedicalDeviceAcademy]

Best of luck! If the project is software, I recommend also purchasing ISO/TR 80002-1. It's a guidance on how to apply ISO 14971 to software.

[@nastaranheidarysharifabadi4648]

thank u, can u help me to find some sample

[@MedicalDeviceAcademy]

Unfortunately there are no standards that have examples. However, Mary Vater recently updated our procedure for software validation (SYS-044). The procedure has updated templates for documentation and has more detail on how to document your software validation. The FDA's new guidance document also provides details on what they want for documenation. Unfortunately, we don't have an example you can copy.

[@MedicalDeviceAcademy]

Thank you Matthew. So many of our clients are not familiar with IEC 62304. Here's a link where people can purchase the standard at a reduced price too: www.evs.ee/et/evs-en-62304-2006-a1-2015 We typically purchase the PDF version in English and we get a multi-user license.