2752784

CEI CEN/TR 17223 [ Active ]

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

standard by Comitato Elettrotecnico Italiano , 05/01/2019

View all product details

Most Recent

Track It

Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $142.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

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.

 

Product Details

Edition:
19
Published:
05/01/2019
Number of Pages:
88
File Size:
1 file , 620 KB