From research I did, there are 6 steps to package development for medical devices. The first step is consulting the regulations. This step is to determine if the medical device falls under the FDA requirements regulations for packaging. The second step is gathering packaging design requirements.The third step is establishing packaging system conformity requirements. This step is to determine the durability of the package. The fourth step is investigating labeling requirements. The next step is conducting distribution and handling tests. And finally perform stability testing, accelerated and real-time aging of the sterile barrier system. This uses the ISO 11607.