Scope for ISO 13485 Certification of a Translation Service Provider

LUFAN

Involved In Discussions
#11
Would that change how you validated it in your opinion? Obviously, risk factor higher, but in terms of how to actually structure the validation? What framework would you pick?
 
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somashekar

Staff member
Super Moderator
#12
Would that change how you validated it in your opinion? Obviously, risk factor higher, but in terms of how to actually structure the validation? What framework would you pick?
Technical translation is different from general translation. As it is your own software, I have no idea about the inputs you have used in the structuring of the translation software.
Having said this, you are simply eliminating the services of a competent translation resource (person) by using the translation software.
The best validation will be you get your software output proof read and approved by a competent person in the specific language and make changes in the software as suggested and get the same verified again and keep the records of this version of the software and the signed off proof document by the competent person along with the CV of that person.
If you assess the risks associated with the software and accordingly cover the above said process in your risk management, to your levels of acceptable mitigation, and you feel justified you are good.
 

LUFAN

Involved In Discussions
#13
I'm not the submitter of the question, and can't speak to inputs. However I agree with probaly involving some verification aspect to the outputted translated documented, I was just trying to think in my head if I had to something like an OQ for such a project trying to scope where translations begin and where they end was unclear and how I could test the software itself.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#14
#17
Technical translation is different from general translation. As it is your own software, I have no idea about the inputs you have used in the structuring of the translation software.
Having said this, you are simply eliminating the services of a competent translation resource (person) by using the translation software.
The best validation will be you get your software output proof read and approved by a competent person in the specific language and make changes in the software as suggested and get the same verified again and keep the records of this version of the software and the signed off proof document by the competent person along with the CV of that person.
If you assess the risks associated with the software and accordingly cover the above said process in your risk management, to your levels of acceptable mitigation, and you feel justified you are good.
If the output is verified each time i.e. the document is proof read, then is validation still required?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#18
Something else to consider if the translation is required to be presented on a UI, does the translation exceed to amount of space allocated to display it? Part of our input requirements to our translator was the character count allowed.
 
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