Package Testing: Developing a Test Plan that Avoids Product Launch

The medical device industry is a fast-changing environment that is continuously adapting to the constant challenges within the medical landscape. One such challenge is designing safe packaging that will protect products during shipping and transport while simultaneously complying with FDA or international health and safety regulations. Many medical device companies struggle with the development of test plans to determine which procedure to specify for package performance testing. And the recent revision to the ASTM D4169 and ISO 11607 standards, as well as FDA’s acceptance of International Safe Transit Associations (ISTA) series 3 standards, add additional layers of complexity.
This presentation will provide an overview of different testing standards, the current status and expectations of the FDA, as well as a discussion on the new guidance, current impact and what may be coming.