Summative testing of medical devices
Every medical device development process finalizes with a summative test.
This is the performance measure for the product and the official proof that the product is safe to use. This requires that acceptance criteria (What must the product be able to do? How safe must it be?) be jointly defined by you as the manufacturer and us, and tested in the test with the users themselves.
Since 2013, we have been conducting such summative evaluations for industry pioneers and market leaders.
The summative test takes place with the production-equivalent device/zero series and systematically checks off all hazard scenarios. It is required that the test condition corresponds as closely as possible to the subsequent use.
The summative test takes place with the production-equivalent device.
The 62366-1 speaks of a test in a simulated usage environment and thereby indirectly specifies the usability test method. It is important to note that no risk may arise for the participant in the summative evaluation, since the product has not yet been approved. Here, the development and implementation of the test cases is a real expert matter.
When conducting summative testing, care must be taken to ensure that participants match user profiles and that all results are appropriately documented.
If errors occur, they are analyzed in detail with the help of a root cause analysis, their causes are derived and possible solutions are worked out.
We support you in the entire process of summative testing – with the know-how from over 500 projects.