Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software.

R

Roland Cooke

#41
Excellent summation Marcelo, thanks. As is often the case, the answer tends to be:
"Yes, but it's more complicated than that." :D
 
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S

Sandor C.

#42
Good Morning Roland,

> But beyond that if a standard is harmonised, your Notified Body will
> essentially expect you to either meet the standard, or have a damned
> good reason why.

There is also a different source of irritation which may force you not to use a harmonised standard. It occurs when the standard which is harmonised to a directive does not include the device (which is assigned to the directive) within its scope.
Let´s give an examle: a dosimeter for QA of radiotherapy linacs.
The dosimeter is a class IIb medical device according to Rule 10(ii) of the MDD.
The EN 60601-1 is a harmonised standard of the MDD and should be applied to medical electrical devices.
The scope of the EN 60601-1 (2nd. Edition 1996_3) implies patient contact or potential patient contact.
The dosimeter is neither used at the patient nor in patient environment. It is not used while treatment delivery. It is used for QA purposes while maintenance or service activities.
So the EN 60601-1 cannot be applied.
What meets perfectly the intended use of the dosimeter is the EN 61010-1, the standard for laboratory measurement devices.
We fulfil Annex I of the MDD with the EN 61010-1 but it is always annoying to explain this always with endless patience to customers who simply wants to see the 60601-certificate.
I admit that compliance to EN 61010-1 is much easier compared to EN 60601-1. But why we should evaluate risks which are not possible at all?

What do you think about that strategy? Do you agree to use a standard which matches the scope? Or would you rather advise to comply with the harmonised standard, even if many exceptions will arise?

Thank you for your answer.
Kind regards
Sandor
 
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max.polix

Involved In Discussions
#43
To go back to the original subject, I wonder how much IEC62304 has been applied by maufacturers so far.
I mean: has anybody an idea of the actual number of certificates of compliance with IEC62304 have been issued by testing laboratories?

I have personally attended some training course on the subject, but no lecturer said more than you can read in the standard yourself.
That makes me think that today the application of the standard is purely theoretical and other requiremnts (FDA V&V for example) still take up the field.
 

sagai

Quite Involved in Discussions
#44
Max,
I do not think if there is any kind of certification about IEC62304 compliance.
Let me put it this way, eventhough there would be a certificate, for what purpose would it be useful for you? Well ... it could give a kind of confidence that at the time of the issuance your operation may complies with it.
But ... i think we are in a great trouble if a third party should tell us whether or not we apply good engineering practices. We should be confident about it anyway!
And also, engineers should inherently apply best engineering practices, not because of a standard but because that is the way how to continuously provide reliable software. Simple is that!

One more thing.
I think regardless this standard keep saying any development method is okay, it still stipulates the waterfall kind of development. I really do not think that any competitive company can afford to accommodate this legacy kind of methodology. But it is not surprising. This standard has a long history back till the 7o's.
Recently, there is a AAMI TIR45:2015 "Guidance on the use of AGILE practices in the development of medical device software" guidance published, that tells you how to apply it to AGILE practices.
But hang on a second ... isn't it insane? Writing up a guidance for a legacy standard to justify how to read the standard when you want to do what 99% of the industry is doing?! And paying for both of these?! Outrageous!

So for me in this standard there are several good engineering practices defined, but unless coming out from the university and looking for some real thing, I see little or no value of it, because professional engineers applying these practices anyway.
Process sequence-wise I think it is utterly obsolete and misleading, only in some really large organization people having no direct contact with the developers may think that work is carried out accordingly.

Cheers!
 
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