Audit requirements and expectations, The good and better about MDSAP Regulations

Abstract

The most sure-fire way to pass MDSAP audit with flying colours is to have an effective Quality Management System (QMS). Having a good QMS will make sure work is correctly documented, kept up to date, and easy to present to an auditor. For regulators too, it means a reduced burden. There is pooling of regulatory resources. The audits are conducted by Auditing Organizations designated by the regulatory bodies. The MDSAP program is expected to improve audit predictability because a standardized audit model has been introduced. Every audit follows the same set of steps. For the first time, a grading system is introduced for noncompliance. This approach helps reduce subjectivity. MDSAP has a very rigid auditing process to ensure the proper market authorizations have been obtained and facility registrations have occurred but not represent Marketing Authorization. Recently proposed greater alignment of FDA Quality System Regulation (QSR) with ISO 13485, would bring US QMS requirements for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.