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  • wms7 replied to the topic Package Development Testing & Documentation in the forum Introduction to Project Management 7 years, 4 months ago

    Not for medical devices, but I’ve been involved with testing shipping containers that would be used to ship out my company’s products. Tests were done with accordance to ASTM D4196-16 specs. These tests involved rotational flat drops of around 3 inches using a quick release mechanism, and vibration for a set amount of hours. The vibration profile was usually truck level with varying degrees of severity, ranging from truck level 1 to 3 which range from 0.40 to 0.75Grms. I’ve also used air level profile but rarely. These tests were selected based on the environment our products would experience during their transit to the customer. If the shipping container passed shock & vibration the doc team would create a report of all observations seen during or post testing and have the container approved up the higher ups.