วัสดุอุปกรณ์การแพทย์ เวชภัณฑ์
เอกสารมาตรฐาน
สหราชอาณาจักร
BSI
PD CEN/TR 17223:2018
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
2018
88
BSOL 2024 online
This Technical Report provides guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.