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Scope of ISO 13485 certification

racglobal

Involved In Discussions
#1
Hello,

With regard to ISO 13485:2016 scope of certification, a device company would like to establish a QMS and be granted a QMS certificate before regulatory approval. Question: The company's manufacturing process may not be ready for audit; but its design and development processes will be. Can the company still apply for regulatory approval under a QMS where the scope covers design and development only? Once they get approval, they will then apply for the scope to expand to manufacturing. This is for Canada. Does this make sense?
 
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JoshuaFroud

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#3
I would like expand slightly on Marcelo's response here,

Yes, it is possible to implement an ISO 13485 based Quality Management System that only encompass, in addition to the mandatory clauses, only the design and development process.

I have worked with a design house that held a 13485 certificate that had no production capabilities, they performed contract design and prototyping of medical devices before passing back to the manufacturer for production hand over.

In your case, however, as you wish to be a manufacturer there is little value in doing this. You cannot apply for regulatory approval to be a manufacturer if you are not able to manufacture anything. As you will be unable to provide evidence that your manufacturing process is to an acceptable standard.

Also as a side note; Canada is now looking for MDSAP rather than ISO 13485 only certification.
 
#4
Hello, I am working in AI-enabled medical software company where this software uses scan images as inputs and provides diagnosis results as an output. However, currently we are ready with only one technology and soon we will be developing other technologies too (It's in design stage). So, is it okay to proceed with one technology now (or mentioning only one technology in the scope) and later add the other two technologies in the scope after development and proper records?
Should I wait till both the technologies are developed (which will take lot of time and hence planning for going with one technology only) or go for the certification for one technology and later on provide the change notification to Notified Body?
Please suggest

Thanking in anticipation.
 

somashekar

Staff member
Super Moderator
#5
Hello, I am working in AI-enabled medical software company where this software uses scan images as inputs and provides diagnosis results as an output. However, currently we are ready with only one technology and soon we will be developing other technologies too (It's in design stage). So, is it okay to proceed with one technology now (or mentioning only one technology in the scope) and later add the other two technologies in the scope after development and proper records?
Should I wait till both the technologies are developed (which will take lot of time and hence planning for going with one technology only) or go for the certification for one technology and later on provide the change notification to Notified Body?
Please suggest

Thanking in anticipation.
You can get started with your ISO 13485 certification process.
Since you mention Notified Body, are you referring to CE mark or ISO 13485:2016 ? please clarify
 

levatorsuperioris

Involved In Discussions
#6
You can apply for design and Development only, but when you implement production you will need another audit (change notification). Given the global situation with Notified Bodies and limited resources, I'm not sure you'll get a notified body interested in auditing twice.
 
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