https://www.iso.org/standard/59752.html ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes www.iso.org ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes ISO 13485:2016 의료 기기 — 품질 관리 시스템 — 규제 목적을 위한 요구 사항 https://e-ks.kr/streamdocs/view/sd;streamdocsId=72059200748806141 KS P ISO13485 의료기기 ─ 품질경영시스템 ─ ..