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ISO 11607-1 CONSOLIDATES MEDICAL DEVICE PACKAGE TESTING STANDARDS

August 17th, 2004

DDL Testing Services Supports New Compliance Requirements for Packaging Materials

MINNEAPOLIS, August 17, 2004 - http://www.TestedandProven.com - Package Testing expert, DDL Testing Services, has voiced its support for a revised and harmonized ISO 11607 Packaging for Terminally Sterilized Medical Devices standard. The International Organization for Standardization (ISO) is revising ISO 11607 in an attempt to harmonize with the European Committee for Standardization (CEN) EN 868-1 standard, meaning that medical device packaging may be required to comply with only one standard instead of a myriad of standards for material, package and product testing requirements.

“Harmonizing ISO 11607 and EN 869-1 has been the goal of the ISO and CEN ever since development of these standards was initiated,” says Patrick Nolan, COO of DDL Testing Services. “Many factors prevented the groups from working jointly on the standard for medical device packaging and each developed their own versions. However, resolutions were passed in each group affirming that efforts should be made to harmonize the ISO and CEN documents in future revisions.”

ISO 11607 currently states that medical device packaging manufacturers “shall demonstrate that, under the rigors of distribution, storage, handling, and aging, the integrity of the final package is maintained at least for the claimed shelf-life of the medical device under storage conditions specified by the manufacturer, as long as the package is undamaged or unopened.”


Watermark Learning Announces IT Training Expansion to Phoenix, AZ

August 9th, 2004

Twin Cities Tech Training Success Paves Way for New Facility in Phoenix

Edina, MN August 9, 2004 http://www.WatermarkLearning.com - Watermark Learning, a MN-based project management and requirements analysis training company, today announced national expansion with the opening of its second training center at the Tech One facility in Phoenix, Arizona.

The success of the Twin Cities based instructor-led training facility and the increasing demand for live training and mentoring in project management, business and software requirements analysis, has spurred Watermark Learning in this expansion.

Stephen Arnold, Business Analyst with a large Phoenix-based financial institution, used to travel to the Twin Cities regularly to take courses with Watermark Learning. He says, “Watermark Learning knows what they’re doing when it comes to professional skills development. Their instructors come from the business world and are 100% in touch with the realities of how the principles they teach are actually put to use.” Stephen Arnold is one of many Phoenix based business analysts, project managers and systems analysis professionals that can now attend Watermark Learning’s skill development courses in Phoenix.


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