Medical Device Single Audit Program (MDSAP) Training

Course Overview

• Course objectives and expectations
• Orientation to the learning materials

MDSAP Overview

• Describe the Medical Device Single Audit Program
• MDSAP Audit Approach documents processes and structure
• MDSAP roles

MDSAP Audits and the Process Approach

• MDSAP as a regulatory compliance audit
• MDSAP audit stages and duration
• The nonconformity grading matrix and escalation rules
• The process approach to auditing
• Risk-based thinking in MDSAP

Exercise! MDSAP Structure

Exercise! Nonconformity Grading

ISO 13485:2016 Review

• Map ISO 13485:2016 clauses with MDSAP processes

Overview of MDSAP Processes

• Management Process (MDSAP Chapter 1)
• Device Marketing Authorization and Facility Registration Process (MDSAP Chapter 2)
• Measurement, Analysis, and Improvement Process (MDSAP Chapter 3)
• Medical Device Adverse Events and Advisory Notices Reporting Process (MDSAP Chapter 4)
• Design and Development Process (MDSAP Chapter 5)
• Production and Service Controls Process (MDSAP Chapter 6)
• Purchasing Process and Annex Topics (MDSAP Chapter 7)
• Process outcomes, tasks, and linkages

Exercise! Identify Potential Audit Questions

MDSAP Country Regulations Overview

• MDSAP as a regulatory compliance audit
• Overview of device regulation in MDSAP jurisdictions

In-Depth Look at Country Specific MDSAP Processes

• Country-specific requirements for MDSAP Chapters 1-7

Exercise! Identify Potential Audit Questions

MDSAP Annex Topics

• Annex 1: Product/Process Related Technologies Technical Documentation
• Annex 2: Requirements for Sterile Medical Devices
• Annex 3: Medical Device Adverse Events and Advisory Notices Reporting Quick Reference
• Annex 4: Requirements for Written Agreements
• Annex 5: Japan's QMS Ordinance Revision
• Annex 6: Acceptable Exclusions from an Organization's Scope of Certification

Implementation Next Steps

• Review real-world MDSAP audit experiences
• Planning and audit readiness
• Planning tools