During design verification, how many samples should you use for testing? A consultant answers the question.
In the “MyQuickConsult Question Grab Bag," a new series, David Amor, cofounder of medical device consultant marketplace www.myquickconsult.com, will answer one question submitted by clients for the MD+DI readership.
Today’s question comes from a start-up in Minneapolis, MN:
Q: We are planning to launch a second generation of a currently existing product in our portfolio for plaque excision. The product is currently undergoing design verification, but we do not have a standard operating procedure (SOP) or work instructions that specify sample sizes. During design verification...