DDL has provided package testing, product testing and materials testing for the medical device industry since 1990. An ISO/IEC 17025 accredited and ISO 9001 certified, third party test laboratory, DDL employs a team of engineers, technical and quality experts devoted to helping customers worldwide succeed by taking an independent, involved and informed approach to ensuring regulatory compliance.
Founded on a commitment to customer service supported by technical expertise, a robust quality system, quick turnarounds and an upfront sales approach, DDL has partnered with companies across the globe to complete over 23,000 projects.
Package Testing Services
DDL’s package testing services evaluate the strength and integrity characteristics of a packaging system before and after simulating the anticipated distribution and storage conditions that the system may undergo. This combination of simulation and evaluation is used by packaging professionals to validate package compliance with ASTM, ISO, ISTA and other accepted industry standards.
- Accelerated Aging Testing
- Distribution Simulation Testing (ASTM D4169)
- Package Integrity Testing
- Package Strength Testing
- Package Validation (ISO 11607)
Product Testing Services
DDL assists manufacturers and engineers in a variety of industries by testing a product’s performance and safety. Specializing in medical devices such as Luer fittings, syringes, needles, catheters, guidewires, cannulae and electrosurgical instruments, DDL tests to ANSI, ASTM, IEC, ISO, JIS, EN and other accepted industry standards. Vibration, physical shock, thermal shock, friction, flow rate, force to operate, leakage and compression testing are among the many tests that are carried out and help medical device developers better understand their products. Custom test development and protocol creation are also provided.
- Catheter Testing
- Medical Connectors Testing
- Guidewire Testing
- Materials Tear Testing
- Product Vibration Testing
Materials Testing Services
To complement its packaging testing, DDL takes design understanding to a deeper level by testing and evaluating the materials that make up the package itself. From tensile and tear testing of poly films and trays to applying compression and tension to packaging components, materials testing can increase an engineer’s understanding of available options, allowing for more informed design decisions.
Processing variables, vendor changes, effects of aging, different sterilization treatments and material changes can be explored through material testing. The engineering staff within DDL’s Product & Materials Division has a thorough understanding of today’s test standards and the principles behind them.
Test Method Validation
Test method validation (TMV) is the documented process of ensuring a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics. TMV is a critical aspect of product development and is becoming a more closely scrutinized part of the development and verification process. TMV can be a resource consuming process for many medical device companies. DDL can assist with the following types of TMV projects:
- Protocol Development
- Test Execution
- Data Analysis
- Test Reports
- Test Method Development
DDL’s Added Value
DDL’s single source, totally integrated approach enables globally recognized corporations to maximize product performance, reliability and safety while seamlessly achieving regulatory compliance. We work hard to build strong relationships with our clients in an effort to partner with them and assist them in getting their product to market on time. We work one on one with clients to ensure all of their testing needs are being met and to direct them to the right test the first time. Our experienced engineers can consult on package, product or material failures and initial design processes when needed.
DDL maintains a high level of data integrity. We promote accurate data, quick turnaround times, the highest level of customer service, and superior quality systems. Our staff is involved with a number of industry organizations such as ASTM, ISO, and IoPP in order to do our job of staying on top of industry trends. We offer the highest level of technical expertise to our customers.
Commitment to Quality
DDL prides itself on its commitment of continual improvement of efficiencies to its quality system. In order to remain successful and support the wide variety of test requirements, we continually improve our quality program in effort to offer superior service within our industry.
DDL makes a strong effort to ensure that our quality system is superior to others in our industry. We make strides to update our processes to help ensure a quick and flawless testing process for our customers.
As part of the quality system at DDL, we have established a documented, implemented, managed and continually improved upon quality management system (QMS). It is managed in accordance with the requirements of ISO9001:2008.
DDL offers full service package testing in Eden Prairie, MN and Fountain Valley, CA. Product and material testing are carried out at the Eden Prairie facility. Both DDL locations work one-on-one with clients providing technical expertise, readily available capacity and individualized, easy to understand, comprehensive quotes.