Medical Device Testing

DDL is your one-stop source for medical device testing and validation — products, materials and packaging, as well as specific tests required for dangerous goods. Our professional engineers and technicians provide reliable, quality-assured testing services and documentation throughout every step of the critically important testing and validation process. DDL has been a leader and innovator in the medical device testing industry since 1990. We offer single-source solutions to medical device development engineers, QA and regulatory affairs professionals who are concerned that their devices meet all regulatory agency requirements and the highest industry standards.

Package Engineer Scott R. Levy

Medical Device Package Testing
Medical device manufacturers are required to obtain 510(K) approval on each medical device package.  DDL performs a variety of testing services to ensure the integrity of the medical device packaging is compliant with ISO standards, such as ISO 11607.

ISO 11607 is the foremost guidance document for validating packaging for terminally sterilized medical devices.  Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments.

Register here for a free FAQ about organizing a medical device package validation.

Medical Device Product Testing
DDL tests and medical devices such as catheters, syringes, needles, cannulae and other intravascular applications.

DDL performs test methods, such as strength testing, luer gauging, flow rate testing and stress testing and many others, on intravascular medical devices to ensure that they conform to ISO standards.

Register here for an article on "Bench-Top Evaluation of Air Flow through a Valved Peelable Introducer Sheath."

For more information on how DDL can serve your medical device testing needs, fill in the contact form below or call DDL at 1.800.229.4235.