The intention of the Medical Device Single Audit Program (MDSAP) is to allow competent auditors from MDSAP recognized Auditing Organizations (AOs) to conduct a single audit of a medical device organization’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program.
Audits performed under the MDSAP program will be process based, focusing on several defined processes, a defined method for linking those processes, and built on a foundation of requirements for risk management.
This document contains specific instructions for performing audits under the MDSAP program. It incorporates an audit sequence, instructions for auditing each specific process and identifies links that highlight the interactions between the processes.
A box emphasizes the interrelationships of specific processes and the relevant risk management activities; if viewing a color version of the document or are in gray boxes if viewing the black and white version. “Blue” font emphasizes the integration of risk management.
This revision of the document combines the formerly separate MDSAP Audit Model and Process Companion documents into a single document containing additional detail regarding each audited process; as well as guidance for assessing the conformity of each process. In electronic form, the navigation bar facilitates quick access to relevant Tasks. The user may create their own bookmarks quickly navigate to various sections.