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
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