EN 62304 and Quality Management System Requirements

M

Mahmood.M

#1
Hello,

i find this website super great and always I get here a lot of new information.

we are a young company. Our quality management system is not yet certified to the ISO 13485 or other standards. We are working on the CE approval of a stand alone software. The standard EN 62304 requires a quality management system in section 4.

This means, as long as we have no QM certificate, we can not bring the software on the market? Is that right?

Thank you very much in advance. :)
 
Elsmar Forum Sponsor
#2
Hello,

This means, as long as we have no QM certificate, we can not bring the software on the market? Is that right?
Not quite.

The use of standards (any standard including 13485) is always voluntary.

What is not voluntary (for European markets) is to comply with the directive and the "Essential Requirements" that it lists.

For the simplest class of medical devices, where there is no requirement to deal with a Notified Body, it would be possible to go to market without a quality system in place. (I do not necessarily recommend this though!).

When you are dealing with higher risk classes of device, where Notified Body involvement is mandatory, then a QMS system will definetley be required especially for software devices which cannot be examined in the same way that more 'solid' products can be.
 

mihzago

Trusted Information Resource
#3
so as Pads38 said, to apply CE marking onto your device you need to comply with MDD (assuming that's what your software falls under).
If it's a class I, you self-certify compliance to the MDD, and theoretically you do not have to follow any quality standards. I agree with Pads38 - not a good idea.

You can use your own standards to demonstrate compliance, but proving that your way is at least as good may be difficult.

So, when you create a quality management system compliant to EN 13485, and meet requirements of EN 62304, make sure you also meet requirements of ISO 14971, and IEC 62366. There may be others too, depending on your device.
 
K

kombela

#4
Sorry to pop in with another question, but it may be beneficial to Mahmood also.
Is it really necessary to have ISO 13485 certification, or "just" full compliance to ISO 13485 (without certificate) is enough to comply with the "(4.1) Quality management systems" part of the 62304?
 
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