The real time stability study gives information on how the quality of medical devices does not vary with time under the influence of a variety of environmental factors such as temperature and humidity.
The protocol contains the real time aging conditions, 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.