Dear all,
Looking at the scope and the introdcution section of ISO 13485, the standard tells what chapters can be left out...for example 7.3 (development).
Basically, ISO 13485 is a standard for medical device manufacturers...but is it possible for companys, which are just suppliers (e.g. component manufacturers) for real medical device manufacturer to obtain an ISO 13485 certification? If yes - why?
Thank you very much in advance for your support.
Best regards,
Aphel
Looking at the scope and the introdcution section of ISO 13485, the standard tells what chapters can be left out...for example 7.3 (development).
Basically, ISO 13485 is a standard for medical device manufacturers...but is it possible for companys, which are just suppliers (e.g. component manufacturers) for real medical device manufacturer to obtain an ISO 13485 certification? If yes - why?
Thank you very much in advance for your support.
Best regards,
Aphel