Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management

Regulatory

Starting to get Involved
#1
Hello Everyone.,,,
Hope all are good and safe...
We are the manufacturer of Class IIb medical devices.. and my query is regarding Annex C of ISO 14971:2012..
# For Medical Devices Questions of Annex C is OK but our medical device have inbuilt software i.e. Acquisition Software and Work Station, for these software these questions will be applicable or not because most of the questions are not applicable in case of Software Risk Management..Please guide we have to consider these ques or not in our software risk management process.

Thanks & Regards..
 
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Benjamin Weber

Trusted Information Resource
#2
First of all Annex C is not obligatory, it is "just" informative. Nevertheless it is a very good idea to apply Annex C in order to follow a recognized standardized set of questions.

Regarding if the questions are applicable for software risk management: Most of the questions are related to "phyiscal" medical devices, but there are also a lot of questions that relate directly (e.g. C.2.19) or indirectly (e.g. C.2.11, C.2.12, C.2.29, C.2.30) to software. IEC 62304 also simply references to ISO 14971 to identify hazardous situations caused by software.

Which question is really applicable to your software depends very much on the way how your individual software works within the medical device and where it maybe implements functions that are relevant for basic safety or essential performance.

To make a long story short: I think you should follow Annex C, even though the majority will not be applicable to the software. But I think you will be surprised, where your software might be relevant!

In addition to the general questions you should think about other methods for identification of hazardous situtations by your software, e.g. FMEA.
 

yodon

Staff member
Super Moderator
#3
Agree with @Benjamin Weber but would recommend considering (also) both the software standard (62304) and the usability standard (62366). You'll see that there's considerable overlap in each for risk management (per 14971). 62304 gives solid direction for software risk management and 62366 gives good direction for characterization and usability.
 

Regulatory

Starting to get Involved
#4
Thanks Mr. Benjamin and Mr. Yodon...I will consider it during Software Risk Management..
I have also confusion that which Software we are using in our medical devices that would be treated as "S/W as a Medical device" or not please guide...
We have two type of Software such as:
(i) Acquisition S/W
(ii) Work station
# Acquisition S/W are the s/w which does not work stand alone, so it requires flat panel for data acquisition, also required sync signals from machine/ Generator. So, our query is, does acquisition s/w is a Medical Device or else?
# Work stations/ PACS can work stand alone, it receives images from Modality and display it. So, does workstation also a Medical Device or else? Please clarify the above said queries..
Thanks..
 

yodon

Staff member
Super Moderator
#5
Hard to say for sure but based on what you describe, I'd think both of them would fall under the medical device regulatory scope with the acquisition software being a component of a system and the workstation software being "Software as a Medical Device" (SaMD / stand-alone software).
 
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