The final version of “ANSI/AAMI SW 87:2012 Application of quality management system concepts to medical device data systems” has been published. FDA initiated and participated in this work. Sherman Eagles, Sandy Hedberg, and Molly Ray of SoftwareCPR were on the working group and Alan Kusinitz of SoftwareCPR was a reviewer. SoftwareCPR can provide MDDS developers new to FDA regulation with training and compliance support focused on efficient approaches.
The document is copyrighted by AAMI so those interested will need to purchase it from AAMI. Note: it may take some time from the date of AAMI’s announcement to committee members until actual availability on their website.