Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
Audit Response / Corrective Actions
If you have audit non-conformance findings from a Notified Body or other quality system audit, a thorough and effective corrective action response is essential to keep your ISO 13485 and CE certificates active. Each issue needs a comprehensive investigation, exhaustive root cause analysis, and detailed action plan with responsibilities, timelines, and effectiveness checks. Your effective actions will ensure a quick close-out of the audit issues and, most importantly, avoid the headaches of suspended certificates or repeat audit findings. Similarly, Notified Body technical documentation review may generate a series of questions that demand complete, timely, and accurate responses to keep your CE marking certification on track.
What will RegPro Medical Do?
If you need to respond to audit and inspection findings, technical documentation questions and comments, RegPro Medical can give you the expertise you need to respond quickly and thoroughly to keep your device on the market or speed through market access. We will assist with investigation, root cause analysis, action plan, and follow-up including effectiveness checks. We will ensure your technical documentation responses address the questions completely and clearly, to avoid additional rounds of questions and keep your CE certification on track.
-
Support Investigation and Root Cause Analysis
-
Help develop effective Action Plans
-
Assistance drafting or updating formal responses