Preparing For Your First FDA or ISO Audit

Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging med device companies all over the globe. We asked our resident FDA and ISO experts, Kevin Chambliss and Chandler Thames, to address clarifying questions we’ve received, and to provide additional key insights and guidance for those preparing for an initial FDA inspection or ISO audit.

Have additional questions for our team on preparing for FDA inspections or ISO audits? We’re here to help.