Update on ISO 13485.
A previous article discussed the impact that new quality management system standards are likely to have on the CE-marking process. The draft international standard for medical device quality systems has now been published. This article will discuss important issues related to the new standard.
Donawa
Maria
M
donawa@srd.it
D004864:Equipment and Supplies / Q000592:standards*; D007391:International Cooperation; D011786:Quality Control; D012015:Reference Standards