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MDSAP Audit and Compliance Training for Medical Device Manufacturers

MDSAP Audit and Compliance Training for Medical Device Manufacturers

$198.00
When you get access:
Course access is prepared after purchase and delivered via email
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Self-paced • Lifetime updates
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Trusted by professionals in 160+ countries
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Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
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What does the MDSAP Audit and Compliance Training for Medical Device course cover?

MDSAP Audit and Compliance Training for Medical Device is covered here in 10 modules: Introduction to MDSAP: Overview of the MDSAP program, MDSAP participating countries, MDSAP Audit Process: Audit process overview, Audit closure and follow-up, Quality Management Systems (QMS) for MDSAP: ISO 13485:2016 and MDSAP and 7 more.

How do you approach MDSAP Audit and Compliance Training for Medical Device step by step?

The work is sequenced in 10 stages. It starts with Introduction to MDSAP: Overview of the MDSAP program, MDSAP participating countries, moves through MDSAP Audit Process: Audit process overview, Audit closure and follow-up and Quality Management Systems (QMS) for MDSAP: ISO 13485:2016 and MDSAP, and ends at MDSAP and Post-Market Surveillance: Post-market surveillance overview.

What is in Module 1 of the MDSAP Audit and Compliance Training for Medical Device course?

Module 1 is Introduction to MDSAP: Overview of the MDSAP program, MDSAP participating countries. It works through Overview of the MDSAP program, History and evolution of MDSAP, Benefits of MDSAP participation and 2 more. It sets the vocabulary the remaining 9 modules build on.

How is the MDSAP Audit and Compliance Training for Medical Device course delivered?

The MDSAP Audit and Compliance Training for Medical Device course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.

How much does the MDSAP Audit and Compliance Training for Medical Device course cost?

The MDSAP Audit and Compliance Training for Medical Device course is $198 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.

Closely related courses: MDSAP Implementation and Self Assessment for Medical, MDSAP Implementation and Self Assessment Checklist, Medical Device Single Audit Program (MDSAP).

More answers: what you get with every course, refund policy, all help answers.

Page updated 2026-10-18.

MDSAP Audit and Compliance Training for Medical Device Manufacturers



Course Overview

This comprehensive course is designed to provide medical device manufacturers with the knowledge and skills necessary to navigate the complexities of the Medical Device Single Audit Program (MDSAP) and ensure compliance with regulatory requirements.



Course Objectives

  • Understand the MDSAP program and its requirements
  • Develop a comprehensive understanding of the MDSAP audit process
  • Learn how to prepare for an MDSAP audit
  • Understand the importance of quality management systems in MDSAP compliance
  • Gain practical experience in conducting MDSAP audits


Course Outline

Module 1. Introduction to MDSAP: Overview of the MDSAP program, MDSAP participating countries

  • Overview of the MDSAP program
  • History and evolution of MDSAP
  • Benefits of MDSAP participation
  • MDSAP participating countries
  • Regulatory framework for MDSAP

Module 2. MDSAP Audit Process: Audit process overview, Audit closure and follow-up

  • Audit process overview
  • Audit types (initial, surveillance, follow-up)
  • Audit planning and preparation
  • Audit execution and reporting
  • Audit closure and follow-up

Module 3. Quality Management Systems (QMS) for MDSAP: ISO 13485:2016 and MDSAP

  • Overview of QMS requirements for MDSAP
  • ISO 13485:2016 and MDSAP
  • QMS documentation and records
  • QMS implementation and maintenance
  • QMS auditing and continuous improvement

Module 4. MDSAP Audit Preparation: Training and competency assessment

  • GAP analysis and readiness assessment
  • Corrective action and preventive action (CAPA)
  • Internal audits and audit scheduling
  • Training and competency assessment
  • Documentation and records preparation

Module 5. Conducting MDSAP Audits: Audit follow-up and closure, Audit reporting and documentation

  • Audit techniques and methodologies
  • Audit sampling and risk assessment
  • Audit reporting and documentation
  • Audit follow-up and closure
  • Audit best practices and lessons learned

Module 6. MDSAP Compliance and Regulatory Requirements: Labeling and packaging requirements

  • Regulatory requirements for medical devices
  • MDSAP compliance and regulatory compliance
  • Labeling and packaging requirements
  • Post-market surveillance and vigilance
  • Recalls and field safety corrective actions

Module 7. Risk Management for MDSAP: Risk management best practices, Risk assessment and risk control

  • Risk management principles and methodologies
  • Risk assessment and risk control
  • Risk management documentation and records
  • Risk management review and update
  • Risk management best practices

Module 8. MDSAP and Supply Chain Management: Supply chain risk management

  • Supply chain management overview
  • Supplier selection and approval
  • Supplier monitoring and control
  • Supply chain risk management
  • Supply chain documentation and records

Module 9. MDSAP and Clinical Evaluation: Clinical evaluation overview

  • Clinical evaluation overview
  • Clinical evaluation requirements for MDSAP
  • Clinical evaluation documentation and records
  • Clinical evaluation review and update
  • Clinical evaluation best practices

Module 10. MDSAP and Post-Market Surveillance: Post-market surveillance overview

  • Post-market surveillance overview
  • Post-market surveillance requirements for MDSAP
  • Post-market surveillance documentation and records
  • Post-market surveillance review and update
  • Post-market surveillance best practices


Course Features

  • Interactive: Engaging video lessons, interactive quizzes, and hands-on projects
  • Comprehensive: In-depth coverage of MDSAP and regulatory requirements
  • Personalized: Learn at your own pace and on your own schedule
  • Up-to-date: Latest information and updates on MDSAP and regulatory requirements
  • Practical: Real-world applications and case studies
  • High-quality content: Developed by expert instructors with industry experience
  • Certification: Receive a certificate upon completion issued by The Art of Service
  • Flexible learning: Access course materials on desktop, tablet, or mobile device
  • User-friendly: Easy-to-use platform with intuitive navigation
  • Community-driven: Discussion forums and community support
  • Actionable insights: Practical tips and best practices
  • Hands-on projects: Apply learning to real-world scenarios
  • Bite-sized lessons: Short, focused lessons for easy learning
  • Lifetime access: Access course materials for a lifetime
  • Gamification: Earn badges and points for completing lessons and achieving milestones
  • Progress tracking: Track your progress and stay motivated


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service, a recognized industry expert in medical device regulatory compliance and quality management.

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