Importance of Vibration Testing Not Realized By Large Percentage of Medical Device Packaging Professionals

MINNEAPOLIS –August 12, 2008 — http://www.testedandproven.com/ — DDL, the leading product and package testing services firm specializing in medical device package testing, recently discovered through the company’s July “Vibration Testing Quizzler” that only 46 percent of Medical Device Packaging Professionals truly understand that vibration testing can prevent defective products or packaging from going to market.

In his winning Vibration Testing Quizzler response, David Anderson VP of Research & Development at GT Urological stated, “When there is the slightest chance that any of our medical products will be exposed to a transportation, operation or storage environment, it is vital that we implement vibration testing before going to market.”

The vibration testing quizzler question below received answers from nearly 200 medical device packaging professionals.

Question: Package and product testing should always be expanded to include vibration testing when there is a chance of exposure to what environments?

Minneapolis, MN, December 6, 2006 – http://www.testedandproven.com – DDL Inc, a leading medical device package, product and material testing laboratory, has been named the #42 fastest growing company in the Twin Cities in a recent Growth 50 honor roll released by the Minneapolis St. Paul Business Journal.

DDL, which has experienced an average annual revenue increase of 25% since 2003, has moved up 8 places from its #50 position in the 2005 Growth 50.  DDL attributes much of its growth to its ability to read the needs of its customers.

“Many package engineers and manufacturers are looking for re-assurance that their packaging will not fail its validation testing,” said Patrick Nolan, COO of DDL Inc.  “DDL offers comprehensive pre-testing consultation via our PackAdvice service pledge, so that the customer feels that the packaging is properly prepared for its testing.”

In 2006, important revisions were made to ISO 11607, the foremost guidance document for medical device package testing.  DDL helped prepare and guide packaging professionals through these revisions with a series of 3 webinars.  DDL has also just launched its “Industry Standards Alert” service, which invites industry professionals to sign up to receive a notification by email or by RSS feed when an industry standard is updated.

Minneapolis, MN, February 27, 2006 — http://www.testedandproven.com/11607-webinar.html - DDL, a leading package, product and material testing laboratory, is hosting a series of free webinars on how upcoming revisions to the ISO 11607 standard will impact packaging professionals.

ISO 11607 is the foremost guidance document for validating packaging for terminally sterilized medical devices. The proposed revisions will mean a change in compliance requirements for package testing and validation.

“DDL wants packaging professionals to be aware of the upcoming changes to the ISO 11607 standard,” said Patrick Nolan, COO of DDL. “Understanding the imminent revisions could mean the difference between pass and fail when it comes to package validation.”

The first webinar, “ISO 11607 Revisions,” presented by Patrick Nolan, COO of DDL Inc, will cover the following:

- Background on the ISO 11607 standard
- Overview of the proposed revisions
- How the revisions will affect requirements for
o Quality Systems
o Sampling Plans
o Documentation
o Sterilization
o Labeling
o Storage & Transport
o Test Methods
- Details and implications of revisions to Clause 6.