Minneapolis, MN, November 18, 2004 – http://www.testedandproven.com/book.html - DDL Inc., a MN-based medical device package testing expert and package testing laboratory, is offering packaging professionals a complimentary copy of “Sterile Medical Device Package Development“, written by DDL Inc. COO, Patrick Nolan.

The article, which Patrick Nolan recently contributed to the Standard Handbook of Biomedical Engineering & Design, overviews the process of designing and developing a sterile package system for a medical device.

“The FDA states that it is the medical device manufacturer’s responsibility to ensure that a safe, reliable, and fully functional device arrives at the point of end use” said Patrick Nolan, COO of DDL Inc. “It stands to reason that the medical device industry should be highly regulated when deficient packaging can so easily cause the loss of sterility to a medical device.”

Recent cases of human infection and fatalities due to the use of non-sterile medical devices have resulted in stricter requirements for medical device manufacturers.

“Medical device product and package testing currently constitutes 85% of DDL’s testing business,” said Patrick Nolan. “In the last 12 months, we have seen our medical device testing sales rise by 20%”