Links
21 CFR 820.181: www.accessdata.fda.gov/script...
ISO 13485:2016 Section 4.2.3: www.iso.org/standard/59752.html
Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/media/87544/download
o Chapter 6
Tasks 16
o Annex 1
What’s the Difference Between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)?, 19Nov2018: www.orielstat.com/blog/medica...
Managing The Device Master Record (DMR) to Comply with 21 CFR Part 11 and Part 820: www.arenasolutions.com/resour...
Requirement name and location
Our requirement, Device Master Record (DMR) comes directly from 820.181. In ISO 13485 this requirement is called Medical Device File (MDF) and it’s in Section 4.2.3.
DMR / MDF requirements in 5 words:
Everything Needed to Build Devices
Негізгі бет Device Master Record 820.181 & ISO 13485 § 4.2.3 Medical Device File (Executive Series #24)
Пікірлер: 3