First there was CE marking...now ISO (International Standards Organisation) 13485:
This article was originally published in Clinica
Executive Summary
Concern over a lack of knowledge among purchasers about the significance of the international standard ISO 13485 quality system (QS) standard for medical devices had prompted a group of European medical device industry associations to issue a joint flyer explaining its value. ISO 13485 is based on the generic international system standard, ISO 9001, but is clearly less well publicised. The European associations that represent device manufacturers, COCIR (radiological and electromedical), EDMA (diagnostics), EUROMCONTACT (contact lenses), EUROM VI (mechanical and optical) and FIDE (dental), have joined together in this initiative which they hope will demystify this particular QS standard and explain its significance to devices sector.