Do you know the following sentence? „Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded“. For sure you do, or? It’s from clause 7.3.7 in ISO 13485:2016. If you are involved in engineering of medical devices, please be reminded to adhere to this requirement. By the way, it applies as well to PQ in the area of process validation. In each of my last three audits I came across one violation in those areas: Non-equivalent design validation lots, PQ having been done with early prototypes or even commerical products not being representative.
