I
I was approached by our customer and they requested that we get EN ISO 13485 certified instead of just ISO 13485. Can anyone explain the difference to me? Is there any reason my customer's notified body would care?
I understand that the "EN" means that CEN, CENELEC or ETSI has adopted a standard as a national standard for Europe, but how does it affect certification?
I understand that the "EN" means that CEN, CENELEC or ETSI has adopted a standard as a national standard for Europe, but how does it affect certification?