Is the software marketed in the USA? if so, section 820.184 provides requirements for the DHR, including DOM, quantity (in my experience with SaMD, we have used a quantity of "one" with each release), acceptance records demonstrating that manufacturing was done in accordance with the DMR, primary label and labeling used, and any UDI or product code used. In 820.120 it also requires labeling inspection to be documented in the DHR. If the software is being reworked due to being nonconforming, this is also required to be documented in the DHR.
Another important requirement to not forget to include is the assessment of the change with respect to usability, safety, performance, functionality, regulatory requirements, risk management etc. (ISO 13485:2016 clause 7.3.9). Rationale for not notifying your Auditing Organization/Notified Body or regulatory authorities should also be well documented.
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
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Original Message:
Sent: 29-Mar-2019 10:01
From: Anonymous Member
Subject: Software Device History Record (DHR)
This message was posted by a user wishing to remain anonymous
Hi everyone,
A company produces software as a medical device (SaMD). In the world of SaMD, can somebody confirm my understanding that a software device history record (DHR) contains the version number and date of release? What other information should be there? I am quite familiar with hardware manufacturing and the DHR in that domain, but I would like to confirm my understanding of the software DHR.
Thanks!