Time and again medical device manufacturers find it challenging to select a suitable performance test procedure to utilize for their packaging system in order to comply with ISO 11607. Although, there are ASTM, ISTA and ISO transit simulation test procedures that may be used according to the distribution cycle for the respective medical device packaging, ISTA tests would usually be the simplest and least expensive process to qualify the packages for performance tests. ISTA never fails to take into account the live lab studies/results and incorporate the industrial standard test cases into ISTA test protocols by working with top packaging industries to help the labs and customers in obtaining the most accurate packaging shipping and distribution test results. The objective of this paper is to explain the concepts of a packaging system, different types of shipping hazards and to develop a customized packaging test protocol or select a suitable one by studying the medical device packaging system in order to comply with European Medical Device regulation (EU MDR), The United States Food and Drug Administration (US FDA) and other regional regulations.
