Links
21 CFR 820.184: www.accessdata...
ISO 13485:2016 § 7.5.1: www.iso.org/st...
Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/me...
o Chapter 6
Tasks 9 & 17
The Importance of DHF, DMR, and DHR, by Joe Pignotti: www.sanbormedi...
Content of DHF, DMR and DHR for medical device software - Part 3 DHR, By Mitch: blog.cm-dm.com...
Requirement name and location: Our requirement, Device History Record (DHR), comes directly from 820.184 and 13485 § 7.5.1.
DHR requirements in 5 words: Proof you followed the DMR
Негізгі бет Device History Record 820.184 & ISO 13485 § 7.5.1 (Executive Series #25)
Пікірлер: 2