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Jan 6, 2017

Investing in Test Method Validation Early Can Pay Off Later

Jan 6, 2017|Medical Device Testing, Test Method Validation|

By Jim McGovern, Validation Manager, DDL

The process of developing a medical device is expensive. A 2010 Stanford University study stated that the average cost to take a 510(k) product from concept to market was $31 million. The cost of high-risk PMA (Class III devices) averaged $94 million. It is reasonable to assume the costs haven’t […]

Dec 19, 2016

ISO 80369-7: Changing the Standard for Luer Connectors

Dec 19, 2016|ISO 80369, Luer Testing, Medical Device Testing|

A few months ago on October 14, ISO formally published 80369 Part 7, the long-awaited replacement to everyone’s familiar friend, ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical […]

Oct 26, 2016

DDL Now Offering ISO 80369 Testing for Small-Bore Connectors

Oct 26, 2016|DDL News, Medical Device Testing, Product Testing|

DDL is now offering testing based on the recently published ISO 80369-7 standard that specifies requirements and test methods for Luer connectors, in addition to the published parts of ISO 80369 for enteral (EnFit) and neuraxial connectors.

For over a decade, work has been underway to develop the ISO 80369 series of small-bore connector standards as […]

Sep 1, 2016

When Do You Need to Do Test Method Validation?

Sep 1, 2016|Test Method Validation|

By: Jim McGovern, Validation Manager, DDL
Recently, I participated in a discussion regarding the role of test method validation (TMV) in new product development. Included in that discussion was a question that comes up frequently, “When do we need to do test method validation?” One of the parties in the discussion volunteered an answer (paraphrased):

You need […]

Jul 11, 2016

ASTM D4169 Truck Profile Update

Jul 11, 2016|ASTM, ASTM D4169, Packaging Validation|

ASTM D4169, the standard practice for performance testing of shipping containers and systems, has recently been updated. The truck vibration data, profiles and testing techniques are the basis for the updates. Following is a summary of the rational for the update.

Rational for Update
In recent years the truck profile data referenced in ASTM D4169 Section 12.4 […]

Jun 9, 2016

DDL PackReview: ASTM-F1929 Dye Penetration

Jun 9, 2016|Medical Device Package Testing, Packaging Validation, Seal Strength Testing|

In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson discuss the following topics on ASTM –F1929 Dye Penetration testing:

What is Dye Penetration?
Why use it?
What are the different methods?
What are the major concerns?
Can anybody do ASTM-F1929?

Dye Penetration is a physical seal integrity test. The test […]

May 31, 2016

DDL Expands Scope of its ISO/IEC 17025 Accreditation

May 31, 2016|DDL News, ISO 17025, Product Testing|

DDL has expanded the scope of its ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ISO 594-2 testing for conical (Luer) fittings.

A conical Luer fitting is the most common means of achieving a leak-free connection between two medical devices (e.g. a syringe and hypodermic needle) that carry […]

Apr 1, 2016

ASTM F88 Package Seal Strength Testing Overview

Apr 1, 2016|Medical Device Package Testing, Packaging Validation, Seal Strength Testing, Uncategorized|

Welcome to DDLs PackReview series on Seal Strength Testing
In this video, DDL Inc Package Engineers Scott Levy and Pete Johnson sat down to talk about the most frequently asked questions they receive on ASTM F88 Seal Strength testing. Some of the questions covered include:

What is seal strength testing?
Why use it?
What are the […]

Feb 3, 2016

10 Things You Should Do Before Your Next Package Validation

Feb 3, 2016|Medical Device Package Testing, Packaging Validation|

Before you set out to validate a medical device package design or process, you’ve got to do your homework in order to understand what is critical to build the proper foundation for a sterile barrier system and to avoid a breach of that system. Scott Levy, senior packaging engineer for DDL, offers the following 10 […]

Sep 18, 2015

DDL Celebrates 25th Anniversary

Sep 18, 2015|DDL News|

DDL, Inc. is celebrating its 25th anniversary of providing package, product and material testing to the medical device industry.

DDL was founded in 1990 by John Hart and Patrick Nolan. Hart and Nolan had previously worked for Eden Prairie based testing products supplier MTS Systems. The two started DDL (originally called Distribution Dynamic Labs) when an […]

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