Medical Device Package Testing

For over twenty years, DDL has been an established leader in the medical device package and product testing industry. Medical device engineering, quality assurance and regulatory affairs professionals rely on DDL as a single source testing provider who can guide them through the details of the test standards and requirements that medical device packaging designs need to fulfill.

By using DDL as a one-stop source for medical device package testing and validation, customers experience the convenience of an ISO 9001 certified lab who tests products, materials and packaging under a proven quality system with degreed packaging engineers and technicians trained to all of the latest test methods. This helps to assure customers that every step of the critically important testing and validation process is carefully executed and documented.

Medical device manufacturers obtaining 510(k) approval on medical devices use DDL’s variety of testing services to ensure the integrity of the medical device packaging and compliance with ISO standards, such as ISO 11607.

ISO 11607 Package Validation for Medical Devices

ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark. ISO 11607 is also a FDA Recognized Consensus Standard. Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use.