PackReview
PackReview is a DDL approved ISO 11607 certification granted to packages that have successfully endured rigorous package testing in order to demonstrate compliance with ISO 11607 (clause 6).
The ISO 11607 Packaging for Terminally Sterilized Medical Devices standard is defined by the FDA and the EU as the paradigm validation protocol for medical device packaging.
Packages that have successfully endured a DDL PackReview receive an official certificate of validation, stating that they are ISO 11607 compliant.
| “With the help of PackReview, DDL provided invaluable assistance in formulating a test plan for our device packaging to meet FDA and ISO requirements. They knocked months off our timeline and were there to help every step of the way. They will be the first place we call when another packaging project comes up.” Laura Bauer Raymedica |
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| "The PackReview certification program should be helpful to medical companies needing a full service packaging validation process." Wayne Schmidt Sr. Manufacturing Engineer Arizant Healthcare Inc |
To receive your PackReview startup kit, fill out the form below or contact DDL at 1.800.229.4235.
