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Medical Device Software - Apps which can control medical devices

Ronen E

Problem Solver
Staff member
Super Moderator
#12
Who cares what a design consultant has stated? This isn't a design question; it's a regulatory question.
Politics begin where it's more important who said something than what they actually said.

I'm not taking sides on whether that person was right or wrong, or whether what they said was relevant or even of any value; regardless, their title is far less interesting to me than their actual reasoning.
 

blah01

Involved In Discussions
#13
Further to the post from @Michael Ayers, with a software app running on a mobile platform to control a medical device, do you guys agree that this enacts 'IEC 82304 Health Software - General requirements for product safety', which has the following definition for the app: "HEALTH SOFTWARE PRODUCTS, within the context of this document, are software-only products. These products are intended to be used with computing equipment not explicitly developed for running the software."
 

Watchcat

Involved In Discussions
#14
their title is far less interesting to me than their actual reasoning.
I'm not sure what titles have to do with this? I didn't cite any titles in my comment.

Titles convey the scope of responsibility and authority that someone has been delegated within an organization; that is the only value I see in titles. (People within an organization typically refer to consultants in lower case because consultants are external to the organization and therefore have no responsibility or authority within the organization.)

I agree reasoning is important, but it's a process, and, like all processes, the quality of its output is heavily impacted by the quality of its input.

If I've been diagnosed with lung cancer, I want the opinion of an oncologist (which is a common noun, not a proper noun), not of a neurologist, no matter how excellent the neurologist's reasoning skills might be. If for some odd reason, the oncologist's title includes the proper noun "Neurologist," he would still be an oncologist, because a title does not an oncologist make. Conversely, if a neurologist's title includes the proper noun "Oncologist," I would still not consult him about lung cancer.
 
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