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The Medical Device Single Audit Program (MDSAP) Series Course Overview

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Title of course: Overview of the Medical Device Single Audit Program (MDSAP) Chapter Structure Course description: This course provides an overview of the chapter structure of MDSAP. Course objectives: • Be aware of the structure of MDSAP audit chapters. Course code: MDSAP00 Title of course: MDSAP Chapter 1 — Process: Management Course description: This course describes the tasks in the first chapter of the Medical Device Single Audit Program (MDSAP), which verifies that top management ensures that an adequate and effective quality management system (QMS) has been established and maintained. Topics in this course include: Purpose, Tasks 1-3, Tasks 4-5, Tasks 6-7, Task 8, Tasks 9-10, and Task 11. After completing this course, learners will be able to recognize the eleven tasks in Chapter 1 of the MDSAP. Learners will also be able to identify linkages between parts of the QMS that are important to auditors and identify considerations and best practices for each task. Course objectives: • Recognize the eleven tasks in Chapter 1 of the MDSAP. • Identify linkages between parts of the QMS that are important to auditors. • Identify considerations and best practices for each task. Course code: MDSAP01 The Medical Device Single Audit Program (MDSAP) series COURSE DESCRIPTIONS

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