This packaging validation template is for the terminally sterilized medical device and to ensure that they remain sterile even when placed on the market. This template covers the requirements of ISO 11607-1 and ISO 11607-2.
This template includes the validation of the packaging machine- Installation Qualification, Operational Qualification and Performance qualification along with the tests mentioned in ISO 11607-1, its objective and acceptance criteria.
This template is written specifically for early-stage medical device companies and is audit-ready and written by highly experienced professionals. Click below to get a preview of this template.