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DDL Now Offering Medical Device Testing at its Irvine, California Laboratory

DDL is now offering select medical device testing at its DDL West laboratory located in Irvine, CA. Testing of catheters, Luers, needles, syringes, guidewires and IV infusion sets is now available at this location. Previously, testing of these products was only available at DDL’s headquarters in Eden Prairie, MN.

The DDL West laboratory recently relocated from Fountain Valley, CA to Irvine, CA. The new facility more than doubles the lab space, which will increase DDL’s testing capacity and ability to grow to better meet its customers’ testing needs. The medical device testing being added is in addition to the package testing (ISO 11607) and ICH stability testing already being offered in this lab facility. Full product, materials and package testing capabilities continue to be offered at DDL’s headquarters.

“The addition of medical device testing to DDL West reflects our commitment to offering our customers the best testing experience possible,” said Corey Hensel, General Manager, DDL. “Having these additional testing services will allow us to provide faster turnaround and reduce development lead time and shorten product time-to-market for our medical device and pharmaceutical customers located in California and the surrounding region.”

The testing being added to DDL’s CA lab will utilize the following standards:

  •     ISO 80369-6 – Medical connectors for neuraxial applications
  •     ISO 80369-7 – Medical connectors for intravascular or hypodermic applications
  •     ISO 10555 – Sterile and single-use catheters
  •     ISO 9626 – Stainless steel needle tubing
  •     ISO 7886 – Hypodermic syringe testing
  •     ISO 8536 – Intravenous infusion set and accessory testing
  •     ISO 11070 – Introducer and guidewire testing

For more information on these tests, or to receive a quote, please contact us or call 800-229-4235.

DDL Relocates its California Laboratory

DDL announced it has relocated its California lab from Fountain Valley to a facility located in Irvine. The new facility more than doubles the lab space, which will increase DDL’s package testing capacity and ability to grow to better meet its customer’s testing needs.

“Our new California facility in Irvine reflects both our continued business growth and our commitment to offering our customers the best packaging and distribution testing experience possible,” said Corey Hensel, General Manager, DDL. “This additional capacity also allows us to provide faster turnaround for our medical device and pharmaceutical customers, which helps reduce development lead time and shorten product time-to-market for all of our customers.”

The new DDL laboratory is located at 9400 Toledo Way, Irvine, CA 92618.

Watch a video tour of the new DDL West laboratory.

Please contact us for more information about our new California testing location, or to receive a quote.

DDL Now Offering ISO 80369 Testing for Small-Bore Connectors

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 an eventual replacement to the ISO 594-1 and ISO 594-2 standards. ISO 80369-7 has been formally published and ISO 594-1 and 594-2 have been withdrawn.

“The ISO 80369 series of standards for small-bore connectors seeks to better address patient injuries and deaths, particularly for Luers, which are used ubiquitously and on many types of incompatible devices and have contributed to many incidences of dangerous medical connections over the years,” said Levi Loesch, Product and Materials Engineer, DDL, Inc. “The timeline for transitioning from ISO 594 to 80369-7 is still to be determined by the FDA. In the meantime, DDL will offer testing to ISO 80369-7 and the other published parts of ISO 80369, while also continuing to offer ISO 594 testing.”

The sections of ISO 80369 include:
• Part 1: General Requirements
• Part 2: Connectors for breathing systems and driving gases applications
• Part 3: Connectors for enteral applications
• Part 4: Connectors for urethral and urinary applications
• Part 5: Connectors for limb cuff inflation applications
• Part 6: Connectors for neuraxial applications
• Part 7: Connectors for intravascular or hypodermic applications
• Part 20: Test methods for each application

Please contact us for more information on ISO 80369 testing and other DDL test offerings.

DDL Expands Scope of its ISO/IEC 17025 Accreditation

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 small volumes of fluids. There are two varieties of Luer taper connections known as Luer-lock and Luer-slip. ISO 594-1 defines the dimensions and validation test specifications of Luer-slip fittings. ISO 594-2 defines the dimensions and validation test specifications of Luer-lock fittings. DDL tests both standalone Luer adapters and Luers which are components of various devices, and has large collection of reference connectors which allows for dramatically reduced timelines to complete testing.

ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL previously achieved ISO/IEC 17025:2005 accreditation for its distribution testing, and strength and integrity testing by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements.

“This expansion of our ISO 17025 accreditation to include ISO 594-1 and ISO 594-2 testing further demonstrates our commitment to continuously improve our Quality system and offer superior service within our industry,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also further demonstrates our technical competency and capability to produce precise and accurate test data our customers can rely upon to meet their regulatory requirements.”

Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s ISO/IEC 17025:2005 accreditation.

DDL Celebrates 25th Anniversary

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 opportunity for a testing lab presented itself.

From 1990 to 2003, DDL operated one testing laboratory at its headquarters in Eden Prairie, MN. In January of 2003, DDL opened a second lab in Costa Mesa, CA. This lab (DDL West) is now located in Fountain Valley, CA. In September of 2007 DDL merged with TCP Reliable, a full service manufacturer for temperature controlled packaging products and phase change materials, located in Edison, NJ. DDL was also one of the first testing labs to receive ISO 9001:2008 certification and recently received ISO/IEC 17025:2005 accreditation.

“We are proud of the vast array of testing services we have been able to provide to the medical device industry over the past 25 years,” says Corey Hensel, General Manager, DDL, Inc. “We consider our success to be a direct result of the loyalty of our clients, the dedication of our employees and the continual improvement of our quality system. We look forward to continuing to work closely with the medical device industry and fulfilling their testing needs.”

DDL Receives ISO/IEC 17025 Accreditation

DDL is pleased to announced its Eden Prairie, MN and Fountain Valley, CA facilities have received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA).

ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2005 accreditation by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements. This accreditation covers distribution testing, and strength and integrity testing.

“Receiving accreditation for our laboratories demonstrates to our customers that we continue to adhere to the highest level of quality assurance,” said Corey Hensel, General Manager, DDL, Inc. “Combined with our recently renewed ISO 9001:2008 certification, the ISO/IEC 17025:2005 accreditation validates DDL’s commitment to continuously improving our quality program in an effort to offer superior service within our industry.”

“ISO/IEC 17025: 2005 is becoming an essential standard for testing facilities serving the medical device industry,” said Patrick Waddick, Quality Assurance Manager, DDL, Inc. “This accreditation further reaffirms our technical competency and capability to produce precise and accurate test data that our customers can rely upon to meet their regulatory requirements.”

Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s ISO/IEC 17025:2005 accreditation.

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