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Medical Device Single Audit Program (MDSAP) series overview

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The Medical Device Single Audit Program (MDSAP) was developed to ensure that a single regulatory audit of a medical device manufacturer's quality management system meets the requirements of the five regulatory authorities participating in the program (Australia, Brazil, Canada, Japan and the United States of America). The program can also help reduce the regulatory burden on manufacturers. There are no additional costs for manufacturers participating in MDAP. They can choose any qualified auditing organization. Additionally, routine audits are scheduled and planned in cooperation with the auditing organization, making the process easier for companies. A full MDSAP audit is comprised of seven chapters: • Chapter 1 Process: Management • Chapter 2 Process: Device Marketing Authorization and Facility Registration • Chapter 3 Process: Measurement, Analysis and Improvement • Chapter 4 Process: Medical Device Adverse Events and Advisory Notices Reporting • Chapter 5 Process: Design and Development • Chapter 6 Process: Production and Service Controls • Chapter 7 Process: Purchasing Each chapter includes multiple tasks to be verified/confirmed during the audit. Each audit task references the applicable clause of ISO 13485:2016 and specific regulatory requirements from the five participating countries. Throughout the audit there is a focus on risk management and linkages between processes. The Medical Device Single Audit Program (MDSAP) series overview UL and the UL logo are trademarks of UL LLC © 2019. This document is for general information purposes only and is not intended to convey legal or other professional advice. Learn more at MasterControl.com

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