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.
Internal Auditing
Internal Auditing is a specified requirement in FDA’s Quality System Regulation and the ISO 13485 standard, but it is not just a regulatory requirement. An effective Internal Auditing program is a valuable tool to identify and correct issues early and each internal audit helps sharpen your organization’s readiness for external audits. To meet these goals of the Internal Auditing process and the regulatory requirements, the internal auditor must be objective and impartial and must thoroughly understand the regulatory requirements.
What will RegPro Medical Do?
When you need a qualified and independent internal auditor, RegPro Medical provides expert, unbiased auditing that frees up your staff to focus on their core responsibilities. Our BSI certified Lead Auditor will equip your team with confidence to handle the toughest scrutiny from regulators and notified bodies with ease and finesse.