Author: Kris Kelly

When should Medical Device Internal Audits be Conducted?

When should medical device internal audits be conducted? The timing of audits in a medical device development and manufacturing company can vary based on several factors. By John Rodriguez Medical device internal audits can...


Top 5 Software Tool Validation Challenges

Facing validation of (non-product) software applications?   This article is for you! Our clients have faced push back from the FDA during submissions, during audits and while attempting certification for the CE label – these...