Yes, and for me, therein lies much of the terror of the coming tidal wave, particularly if these devices will be developed mostly outside the established medical device industry.
I would lament the choice of "Medical Device Software" as an appropriate term to refer to the same thing as SaMD. There is already a lot of software that is part a medical device, rather than being a medical device on its own. I think most people would assume that this term refers to both and, if not to both, to the former, rather than the latter. From a purely literate perspective, that assumption is well justified, too.
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Julie Omohundro, ex-RAC (US, EU), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 27-May-2016 08:46
From: Michael Zagorski
Subject: "Stand-alone Software" from a UDI perspective
The latest revision of the IEC 62304:2006 ADM1:2015 (the 2015 amendment) introduced the term "Medical Device Software", which is used 38 times throughout the document including the title and appendices.
It appears however, that the terms "Medical Device Software", "SAMD - Software As Medical Device," and "Stand-Alone Software" mean the same thing and are consistent with the definitions provided in earlier posts.
For software developers, especially those not very familiar with medical device regulations and standards, the terminology can be quite confusing. For many, terms such as 'device', 'design transfer', or even 'design' are confusing or meaningless. You may have a software developer that rewrites half the code and still claim there was no change to "design".
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Michael Zagorski RAC, CQA, CQE
Pittsburgh PA