DDL Package Testing Engineers are proud to offer PackReview as an addition to their suite of growing PackServices. PackReview is the DDL approved ISO 11607 clause 7 certification granted to packages that have successfully endured rigorous package testing in order to demonstrate compliance with ISO 11607 (clause 7).
"With the help of Pack Review, DDL provided invaluable assistance in formulating a test plan for our device packaging to meet FDA and ISO requirements," said Laura Bauer of Raymedica. "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."
The ISO 11607 clause 7 packaging for terminally sterilized medical devices standard is defined by the FDA and the EU as the paradigm validation protocol for medical device packaging.
"As a leading medical device package testing laboratory, we are committed to providing high quality testing services to our clients," said Patrick Nolan, President of DDL. "Our intention is for PackReview to become recognized industry-wide as a respected certification that verifies a package's compliance with ISO 11607 clause 7."