ISO 13485 certification scope

Rakan900

Registered
Hello everone,
We are a designer of a medical product which will be manufactured by another party. We would like to get a 13485 certifcation with the scope of Design and Developemnt only. Is this possible? if yes, to what extent the standard/certification requires that we be involved in the manufacturing process (such as auditng our partners or so)?
Finally, What articles we should satisfy from the standard given our scope?
Thank you
 

DannyK

Trusted Information Resource
Hi Rakan900,
Will you be considered the legal manufacturer or are you providing the design service to the legal manufacturer?
Will your company name be on the label?

Danny
 

Rakan900

Registered
Hi Danny,
We will not be considered the legal manufcturer. We are providing only the design.
Our company name will not be on the label.
Thank you
 

yodon

Leader
Super Moderator
Sounds like you'd just be providing design services up to and possibly through design transfer. Yes, you can get certified (this is basically what my company does and we're certified). Other than the sterilization, implantables, and reporting to regulatory authorities clauses, pretty much everything else is in scope. You have to look at it a bit differently: your (design) service is your product. There are some other subtleties. Have a go at it and post where you're having difficulties.
 

DannyK

Trusted Information Resource
Hi Rakan900,
As Yodon mentioned, there is no problem to get ISO 13485:2016 with the scope of Design and development services.
You have to go through clauses 6, 7 and 8 to determine any Non-applicable clauses.

I hope this helps.

Danny
 

chetan

Registered
Hi Danny,
We will not be considered the legal manufcturer. We are providing only the design.
Our company name will not be on the label.
Thank you

Without any legal document, ISO 13485 certification not possible. Certificate is not provide to person, it provide to legal firm. it is management system & it is applicable to any firm.
 
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