The Accelerated Stability Study is designed to increase the rate of chemical degradation and physical change of a device by using exaggerated storage conditions. The accelerated stability study protocol and report is prepared as per ASTM 1980-07.
The protocol contains the accelerated aging conditions (test temperature, humidity, cycle, ambient temperature), time frame, sample sizes, sterile barrier system description, time intervals of sampling, and specific tests at each time interval. While the report summarizes the results and concludes on the shelf life of the device.
This template is written specifically for early-stage medical device companies and is audit ready and is written by highly experienced professionals. Click below to get a preview of this template.