Protocol Development & Review
Medical devices are a unique class of products that we inherently trust to be functional and sterile when a medical procedure is performed using these devices. The process outlined in ISO 11607 is designed to subject the packaged products to a very intensive replication of the distribution and storage environments. If the products survive this distribution testing in a sterile and functional manner, a very high confidence level can be placed on the ability of the product and package system to survive normal distribution in a similar fashion.
A good protocol meeting the requirements of ISO 11607 addresses sample size, quantity of shippers to be tested, defines the test inputs and references the appropriate standards. Dimensions and drawings of the packaging are helpful. Well thought out acceptance criteria and flow charts or diagrams are helpful to clarify as well.
If you'd like your protocol to be reviewed, contact us!