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

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Robetguevara

#31
Hi, first of all sorry to come in the middle of the forum, but I have been getting familiar with the 62304 and with the ISO 15504 SPICE. Please correct me if I am wrong. But can the requisites established by the 62304 be accomplished by applying SPICE oriented to the software medicine field?
The way I see it, 62304 is a most straight forward standard specifically oriented to the medicine field. However by means of using SPICE, the whole implementation of the product (software) could be carry out. Since the 62304 does not cover validation.
Has someone knowledge about their coexistence, and if is it possible to think of 62304 as a part or the 15504.

Thanks and have a good day.
 
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Watchwait

#32
I'm hoping Marcelo can weigh in on this one as well. As I understand it, 62304 speaks to software life-cycle development, and IEEE 1540 addresses risk management during software development. I too would like to know the relationship of 15504 to these other standards.
 
M

mikezv

#33
Has anyone a checklist for the 62304? I had a checklist for 60601-1-4 and am looking for one for an assessment according to 62304.

Thanks.
 
S

Sandor C.

#34
Hello Alexander,

I would warmly recommend to you this article of David Vogel:
please google "Software Safety for Every Phase of Software Development"

It is very interesting and gives you a good impression about software risks.

Enjoy :)

Regards
Sandor
 

Marcelo

Inactive Registered Visitor
#35
ISO 15504 is a MODEL frameworkfor software development. IEEE 1540 is a MODEL framework for software risk management.

IEC 62304 is a MODEL framework for medical devices software development, as ISO 14971 is a MODEl framework for risk management of medical devices.

There are a lot of MODELS for software development, as there are a lot of MODELS for software risk management. You can use anyone you see fit for your organization, but surely using the ones developed for the medical devices industry makes life a lot easier.

This always comes back to my main point of view. You can use any information (standards, books, articles) you want, but you have to know what your doing.
 
W

Watchwait

#36
Marcelo, this has nothing to do w/EN 62304, but I've come across another standard (and Title!) which is even more obscure to me: "IEC 62296-2003 Unaddressed safety aspects of the 2nd ed. Of 60601-1".

Can the intent and applicability of this standard be boiled down to one or two succinct statements?:thanx:
 

Marcelo

Inactive Registered Visitor
#37
IEC 60601-1 2nd edition has a lot of flaws. IEC TR 62296 (there´s a second edition of this TR that´s just been published in earlier 2009) details some of the problems, mainly addressed by users of the standard, and gives some explanation (recommendations) how to deal with them - these are very technical in general (for example, when you use table Xa to deal with temperature of components, you have to correct the ambient temperature to 40 degrees, which is the limit of the standard. This is not obvious and a lot of people would just use the measured temperature at the ambient temperature, without correcting, giving erroneous - generally much less - values to the test).
 
R

Roland Cooke

#39
Just to clarify the general situation regarding standards.

For compliance to the European MDD no standard is mandatory. That includes ISO13485, even if you go down a quality systems route.

However ISO13485 is a harmonised standard.

As with all harmonised standards, if you can demonstrate that you meet it, you are presumed to comply. So it's simply a good idea.

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.

So for assessing your quality system, you could opt to do your own thing - and that is perfectly 'legal' - but be advised that I will be carrying a copy of ISO13485 around as my reference tool. No I can't give you non-conformities against ISO13485, but I can - and will - raise them against the relevant section of MDD.

In reality, people just go for compliance to ISO13485, and get a certificate to hang on the wall. If a company holds valid ISO13485 from another registrar and transfers to SGS for MDD/ISO13485 certification, we will take that existing registration into account.

A more real-world example might be biocompatibility for example. The harmonised standard is ISO10993, there is a matrix in Part 1 that details what tests (or justifications at least) are required, depending on site of body contact and the length of time of that contact.

Again there is no absolute requirement to meet ISO10993, as no standard is mandatory. But ISO10993-1 is a harmonised standard, and I will use it to establish what tests/justifications should have taken. If there's a gap, I'm writing a non-conformity.
Typically of course we might be talking about a US company that has met the USP. The use of the USP is generally accepted to be a valid alternative to ISO10993, with the proviso that I would expect that company to compare the USP against the ISO10993 requirements and justify any discrepancy, perhaps performing additional tests.


Edit: Other countries (e.g. Japan) may have a different requirement when it comes to standards. Compliance to ISO13485 is mandatory under the CMDR in many cases for example.

Hope that helps.
 
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Marcelo

Inactive Registered Visitor
#40
Great explanation as always Roland.

I do agree with everything you said, but my point of view (and the one i always try to disseminate in my answers) is that manufacturers should take care with their use of standards. There are a lot of problems with using standards or harmonized or recognized standards, and one the problems i´ve noticed by experience, at least here in Brazil, is that when you put in the head of a manufacturer that he HAS to use some or alot of standards (and i know a lot of certification house \ notified bodies which "sells" to a manufactuer that his only option is to use the standards) it results in the manufacturer having a "narrow view" of the whole regulatory scheme system, and this has a negative impact on the safety and effectiveness of the device (which is generally what reg schemes are about). This happens because, among other things, manufacturers tend to think that only complying with a standard or some standards will make their equipment safe.

Take your biocompatibility example. A lot of manufacturers tend to think that all biological safety can be dealth with using the ISO 10993 series, mainly because they are are known standards and certification \ notified bodies always asks for that. But, although biocompatibily IS a requirement from the MDD (explicited in 7.1 of the essential requirements), the MDD is in fact not asking just for that (it´s obvious when you note that 7.1 says "Particular attention must be paid to: .....some points" - it does not mean that you have to pay attention to ONLY those points). In fact, what the requirements asks is for a evaluation of biological safety, and biocompatibility is only an aspect of biological safety (for example, biocompatibility is concerned with interactions between tissues and materials, with regard for example for irritation - it´s not concerned, if the material is poisonous or not, so there can be poisonous materials with are biocompatible....clearly this is not what the regulatory requirements want!).

But, as everyone talks about biocompatibility standards, ISO 10993, and everyone asks just for biocompatibility studies, manufacturers are clearly overshadowing the "big picture" concern of biological safety (again, this is from my experience in Brazil mainly, but i know that this happens abroad too). This is an example of what i fear when using standards.

So, again, i do agree totally with you, and would indicate that manufacturers should always use standards because they facilitate a lot of things (including assessments from regulatory authorities). But i will also advise that they know what they´re doing, because blindly following the advice of using standards without really knowing why they can use it, or why it´s best to use them (even if they´re not compulsory) is a risk for their business and might put them into trouble sometime.
 
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