ISO 62304 Software Risk Management and Medical Device Class

I'm trying to get my head around 62304 and risk management

we have a class IIb device upon which a full risk analysis has been performed (adhering to BS EN 14971:2009) - do we need to do separate risk analysis for the software? Is there any guidance document on additional questions you should ask outside of those suggested by 14971? I have been assuming that one was enough but I don't want to leave myself short

Today I've got myself very confused with the standard which I thought I had in the bag.. do I need to specify the class of this software in addition to the device class - I've just realised our company has never been pulled up before for not having done so - is our device essentially two medical devices (eg class IIb and software class A)?

Re: Software Risk Management and class

If you have a full risk management which takes into account all hazardous situations (including the sequence of events) which might be caused by software, then it would be ok.

But, by your questioning, i´m pretty sure you don´t.

Take a look at IEC/TR 80002-1 Ed. - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software, i think the name is self-explanatory

The software class in IEC 62304 is only there to allow the separation of requirements in the standard. You do have to specify the software class to apply the standard, but this has nothing to do with the regulatory risk class of the medical device regulations (although there are some links).

Re: Software Risk Management and class

thanks mmantunes, I'm going to purchase this today!

Re: Software Risk Management and class

there are some free reading in this subject:

1., Implementation of risk management principles and activities within a Quality Management System
http :// www. ghtf. org/documents/sg3/sg3n15r82005.pdf - BROKEN LINK UNLINKED

2., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm

And yes, if you did a full all sequence of event based rm already, you do not have to.

Moreover for certain markets there is a different hazard classifications, for EU there is MDDs with ERs one "general" and one for in vitro md.
As far as I know, there is a separate for Canada also.

These are slightly differently categorized than the hazard categories you can find in147971.

regards
Sz.

Re: Software Risk Management and class

Marcelo, I am in the process of developing a Risk management Plan for a IIb device, do you have an update to you template posted in 2010 (I think)? Perhaps this includes some 62304 specific items?

Marcelo, I am in the process of developing a Risk management Plan for a IIb device, do you have an update to you template posted in 2010 (I think)? Perhaps this includes some 62304 specific items?

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Hello, and welcome to the Cove!

No, I haven´t update it yet, I´m waiting for the revisions and guidance documents on the standards to do that..but this will take a while!