-
hg93 replied to the topic "Combination Product Phase I clinical Studies" – 5 years, 10 months ago
Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks: Identification of… Read more»