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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.
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.
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