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Medical Device Single Audit Program (MDSAP) Training

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to consolidate compliance audits from several markets or Regulatory Authorities with a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States participate in the program. This training class provides a solid understanding of the MDSAP program, what to expect during an MDSAP audit, and the key regulatory requirements for MDSAP-participating countries. We also offer a MDSAP auditor class

Compare Classes

We Offer Two MDSAP Training Classes. Which One is Right for You?

SkillsLab Class ?
DaySmart Class ?

Class Content

In-Depth

Foundational Overview

Class Duration

4 Half-Day Sessions*

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Virtual

Certification of Completion

Yes

Yes

Continuing Education Units (CEUs)

1.6

0.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Medical Device Single Audit Program Training

SkillsLab $2195

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
SAF VIRTUAL DELIVERY (Eastern Time) 03 Jun 2024 06 Jun 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

DaySmart $995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
SAD VIRTUAL DELIVERY (Eastern Time) 18 Jun 2024 18 Jun 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
SAD VIRTUAL DELIVERY (Eastern Time) 16 Jul 2024 16 Jul 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
SAD VIRTUAL DELIVERY (Eastern Time) 10 Oct 2024 10 Oct 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
SAD VIRTUAL DELIVERY (Eastern Time) 04 Dec 2024 04 Dec 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

MDSAP Training: How Deep Do You Need to Go?

Our DaySmart option provides a foundational overview of the MDSAP. You'll walk away with a solid understanding of the essentials of compliance. Our SkillsLab class goes deeper into more areas of the MDSAP audit process and participating country requirements, with additional hands-on exercises to apply your knowledge. See the table below and choose the option that fits your needs.

 

Course Overview
SkillsLab Class
DaySmart Class

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
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab
DaySmart

Present an overview of the MDSAP

Describe the MDSAP audit approach document and how it is used, including objectives, the evidence sought, audit tasks, process linkages, and the emphasis on risk management 

Explain how MDSAP auditors use the nonconformity grading matrix 

Identify the characteristics of a process-based approach to auditing, as used in MDSAP 

Country-specific requirements in the MDSAP audit approach 

MDSAP audit readiness preparation steps 

Who Should Attend

Who Should Attend

Anyone from the medical device industry with responsibility for one or more elements of the organization’s quality management system, including auditing. Also ideal for medical device manufacturers who desire an overview of MDSAP and its potential benefits.

  • Quality Managers
  • QMS Auditors
  • Regulatory Compliance
  • Senior Management
  • Engineering

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