Verification software - EN 62304 applicable?

K

kanwal

#11
Oops! I misunderstood your question in the first instance.

EN 62304 is a harmonised standard. It is the preferred way to prove conformity with ESR and the requirements of the directive.

Hope I have it right this time.
 
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sagai

Quite Involved in Discussions
#12
For me it is only one way of doing things, it is nowhere said "preferred".
Think about this!
When there is a company and it does a hell of a lot job to comply with this 62304, what does it mean for the company? The benefit I think is only for the company itself rather than from the regulatory prospective. Regulators, notified bodies do not investigate the compliance with 62304, the scrutiny is only based on the legislation itself and based on in case the company for EU legislation voluntarily claim compliance with ISO13485, than it based on ISO13485. That's all.
Sometimes I feel a kind of endless crusader duty to spread these, I have no idea where the blind devotion to all standards are coming from (however I do benefit of reading those of course, but not blindly) ...
Cheers!
 
K

kanwal

#13
Please take time to read Article 5 of MDD.

The preference of harmonised standards as the chosen route to prove compliance with the requirements of the directive and specifically the ESR will be clear.
 

sagai

Quite Involved in Discussions
#14
Let make this part of the question right ... when there is a harmonised standard and not explicitly mandated by the legislation, like this IEC62304, it up to the manufacturer's sole discretion whether or not voluntarily bind itself to such standard.
... and I am in peace now ...

however, there was another part of the story, and I am wondering if this piece of software sold along with the medical device to the customer, or it is only for the manufacturer's testing kind of software.

Cheers
 
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K

kanwal

#15
Harmonised standards, as I understand, are not mandated but are voluntary. The benefit of the use of harmonised standards is stated at http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/ as


Compliance with harmonised standards provides a presumption of conformity with the corresponding requirements of harmonisation legislation. Manufacturers, other economic operators or conformity assessment bodies can use harmonised standards to demonstrate that products, services or processes comply with relevant EU legislation.

The harmonised version of IEC 62304 is EN 62304. Use of IEC 62304 for proving conformity will require additional effort in proving compliance with the requirements. While using EN 62304 in the conformity assessment will provide a presumption of conformity with the regulations.

To illustrate this point, allow me to refer to ISO 13485: 2003 and EN ISO 13485: 2012. One of the essential differences between the two standards is that

ISO version permits claim design and development exclusions in select cases (Clause 7.3),
while EN ISO 13485:2003 does not permit exclusion to this clause if Annex II is the chosen conformity assessment route.

In regard to the second part of your statement - MDD is not applicable if the software is part of the testing only and is not contained in the device that is placed on the market as it is not a medical device, as submitted in my earlier post. The appropriate harmonised standard would be dependent on the nature of the device in which it is loaded. Since the use would define the applicable directive and the conformity assessment route and appropriate harmonised standard will be prescribed by that directive.
 

glork98

Involved In Discussions
#16
Rolling back a bit...

I say "no" to full 62304 compliance. If it is used in manufacturing the use of it needs to be validated. This is part of process qualification.

It's clear that if the software was to be operatred by customers as part of a medical device then it'd need to be done per 62304. If you had software that was used as an active part of providing patient care and it was in-house (E.g., processing data) then it would be, too. Custom software used in manufacturing only needs qualification that it works correctly.
 

Marcelo

Inactive Registered Visitor
#17
My company sells medical scales which require EC verification.

I'm responsible for creating and maintaining the verification/calibration software used to enter measurement data, verifying the results, printing the labels as the type plate and printing the certificate / CE conformity declaration. The software is not sold but only used internally.
The central calculations of software are validated, however the larger part of the requirements of EN 62304 (for Class A) like software architecture/design plans are up to now only in my head.

Our last auditor told us, that the software could be considered medical software, as it may have influence on the quality of the product.

Is this correct? Should the software be considered a medical software?
No, it's not medical device software per IEC 62304.

But it's a software used in the medical device quality system. It needs validation, and the only standard dealing with this right now is AAMI TIR36:2007 - Validation of software for regulated processes (IEC is developing an international standard with this objective but it will be published in a few years only).
 
K

kanwal

#18
I agree that it would be part of process validation.

AAMI TIR 36:2007 would be applicable if it is a medical device. Having agreed that it is not a medical device, the applicability is under a cloud.

However, In the context of EU (arising from seeking compliance to MDD), there is a concept of first 'put to use' in the New Legislative framework - where even if it designed and then put to use within the premises, it would need to conform to appropriate directive provisions.

Other standards that could cover this aspect are ISO 13849 (if it is part of a machinery under the EU definition), ISO 12207 (general software), IEC 61508-1 (prgrammable electrical equipment).

Thus without knowing the complete details, the way forward is not feasible to be ascertained precisely.
 

Marcelo

Inactive Registered Visitor
#19
AAMI TIR 36:2007 would be applicable if it is a medical device
Nope. AAMI TIR 36 is for software used in the quality system, including production, not to medical device software.

The IEC standard dealing with this subject is going to be related to the requirement in ISO 13485 related to validation of process software (which is related now, in 7.5.2.1, only to production and service software, but will be expanded in the revision of ISO 13485 to be the same as the 820 70 requirement on (i)Automated processes, meaning, all quality systems software processes).
 
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