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Archive for August, 2004

ISO 11607-1 CONSOLIDATES MEDICAL DEVICE PACKAGE TESTING STANDARDS

Tuesday, August 17th, 2004

DDL Testing Services Supports New Compliance Requirements for Packaging MaterialsMINNEAPOLIS, August 17, 2004http://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.”The revised ISO 11607-1; Part 1 and Part 2 standards are designed to harmonize with EN 868-1, outlining specific requirements for material testing, validation of medical device packaging and specified shelf-life. ISO 11607-1 incorporates UN 868 Part 2-10, which only includes specific requirements for commonly used materials. By harmonizing with EN 868-1, ISO 11607-1 now includes specific general requirements to be satisfied by all medical device packaging materials.”Compliance to ISO 11607-1 requirements will ensure that medical device packaging maintains its integrity for the duration of the medical device’s specified shelf-life” says Patrick Nolan. “The best way for manufacturers to confidently affix valid expiration dates to their products and avoid package deterioration is to ensure that their package is submitted to accelerated aging testing.”DDL Testing Services offers free pre-and-post package, product and material testing consultations to help meet and exceed ISO 11607-1 and other industry standards.About DDLDDL offers expert package testing services that provide superior testing and excellent documentation for package testing, material testing, product testing and HazMat testing. DDL package testing clients find value through its zero-cost package consulting service, Pack-Advice. DDL maintains full service testing labs in Minnesota and California. Contact DDL at www.TestedandProven.com or call Scott Levy at 952-941-9226 ext.115.###

Watermark Learning Announces IT Training Expansion to Phoenix, AZ

Monday, August 9th, 2004

Twin Cities Tech Training Success Paves Way for New Facility in PhoenixEdina, 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.”Phoenix is now the 5th largest city in the country, and we believe that it is a location that will experience significant business and IT growth in the very near future,” said Richard Larson, Watermark Learning Principal. “The competitive climate is favorable for us, and we have several Twin Cities-based retail, manufacturing and financial clients with Phoenix branches in need of project management and requirements analysis training.”According to recently released federal statistics reported by the Phoenix Business Journal, “Between June 2003 and June 2004, the Phoenix/Mesa metropolitan area netted 41,200 jobs. That’s second best in the country behind only the Washington D.C./Northern Virginia market…according to the U.S. Bureau of Labor Statistics.” The same report stated that “Phoenix’s year-over-year job gains outpaced rival Las Vegas (which added 38,800 jobs) and other markets that showed improvements such as St. Louis (32,400), New York (31,800) and Atlanta (27,100 jobs added).”Watermark Learning’s new Phoenix based training facility, co-located with consulting firm Tech One, will offer a variety of project management and requirements analysis based courses developed specifically for project managers, business analysts, and software developers.Courses available, beginning September 20, 2004 at the Watermark Learning/Tech One facility in Phoenix, AZ include:· Gathering Complete Business Requirements – 2 Day Course· Use Case Modeling – 2 Day Course· Business Process Modeling – 2 Day Course· Managing Small Projects – 2 Day CourseTo learn more about the project management and requirements analysis classes now being offered by Watermark Learning to Phoenix-based business professionals visit: http://www.watermarklearning.com/Public_Classes_Phoenix.html or call 800.646.9362.The Watermark Learning training facility is located at:Tech One,3922 E. University Drive, Suite 2Phoenix, Arizona, 85034About Watermark LearningWatermark Learning is a leading project management and requirements analysis skill development company. It offers training and mentoring on Project Management, Requirements Analysis, Leadership, and Software Development. Clients include professionals from Wells Fargo Bank, 3M, GMAC/RFC, Minnesota Life, ING/Reliastar, MetLife, State of Minnesota, and other Fortune 500 and smaller organizations.To learn more about Watermark Learning visit http://www.watermarklearning.com or call 952.921.0900 or 800.646.9362.###

 
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