Hello Anon,
In simple terms ISO 13485 is a Quality Management System standard, IEC 62304 is a life-cycle management for any type of software, and IEC 82304 is also a life-cycle management for any type of Stand Alone software (and also does not necessarily needs to be regulated as a medical device). This means there is overlap, conjunction, and individual components from each of these standards. If you think of some balloons or a pyramid, ISO 13485 is the biggest balloon which is for QMS, IEC 62304 is for any software in a medical device or stand alone which is the next smaller balloon, and IEC 82304 would be the smallest balloon for stand alone software. If you have a stand alone - Software as a Medical Device (SaMD), the term can apply the same to medical devices and IVD medical devices, then most likely you would apply all three standards. IEC 82304 is also a "process" standard but used in conjunction with the other two. Hopefully that helps.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 12-Apr-2024 09:48
From: Anonymous Member
Subject: Applicability/inter-relation of IEC 62304, IEC 82304 and ISO 13485
This message was posted by a user wishing to remain anonymous
I was wondering if anyone can shed some light on a question I have about IEC 82304-1:2017.
The company I work for develops a software IVD (there is no hardware so it is a SaaIVD) and the current applicable markets are UK and EU. We design and develop in accordance with our ISO 13485:2016 QMS, and also apply IEC 62304:2006+A1:2015 to our software development.
Having looked at IEC 82304, it seems that is is applicable for us (based on the helpful diagram in figure A1 of the standard) but I am a bit confused about what it brings to the process, over and above what is already covered by ISO 13485.
It seems that IEC 82304 is intended to be used with IEC 62304 to bring in aspects such as validation of the product with respect to user requirements, which are missing from IEC 62304. I understand that if you are making health software which isn't a medical device (and therefore not applying ISO 13485, clause 7.3) then IEC 82304 plays an important role, but surely otherwise ISO 13485 7.3 covers validation already?
I'd really appreciate any additional insight.
Many thanks in advance.
(NB I am aware that IEC 82304 is not a designated standard under UK MDR 2002 or a harmonised standard under EU 2017/746, but it does appear to meet the criteria of state of the art)