Medical device manufacturing is governed by FDA 21 CFR Part 820, Quality System Regulation, and/or ISO 13485 Medical Devices Quality Management System Requirements.

Please accept our free download of a medical device manufacturing inspection sheet in hopes that it makes the process a little easier and less time consuming.

If by chance, you do not want to fill out these forms by hand, we do offer the industry leading software that builds the report for you from PDF or TIF drawings and 3D models.


The DISCUS Software Team