Certified MDSAP & FDA QMSR Lead Auditor Training
The MDSAP and QMSR Lead Auditor Certification Training by TÜV SÜD is an intensive five-day programme designed to equip medical device professionals with the knowledge and practical auditing skills required to conduct effective first-party, second-part, and third-party audits in accordance with Medical Device Single Audit Program (MDSAP) requirements and FDA Quality Management System Regulation (QMSR). The training provides a comprehensive understanding of regulatory expectations, audit methodologies, risk-based auditing principles, non-conformity grading systems, and country-specific regulatory requirements of participating MDSAP authorities. Through workshops, case studies, mock audits, and practical exercises, participants gain the competence required to plan, execute, report, and follow up on audits within the global medical device industry.
Career Path Objectives
- Understand the structure, objectives, and regulatory framework of MDSAP and FDA QMSR
- Develop competency in conducting effective MDSAP and QMSR audits
- Learn audit principles and methodologies based on ISO 19011:2018
- Gain practical knowledge of audit planning, execution, reporting, and follow-up activities
- Understand MDSAP non-conformity grading and reporting systems
- Interpret regulatory requirements across participating MDSAP countries
- Develop skills for evaluating medical device quality management systems
- Enhance capabilities in identifying compliance gaps and regulatory risks
- Fundamentals and regulatory structure of the Medical Device Single Audit Program (MDSAP)
- FDA QMSR requirements and alignment with ISO 13485
- Audit methodologies based on ISO 19011:2018
- Audit planning, checklist preparation, evidence gathering, and reporting techniques
- MDSAP audit sequence, task structure, and non-conformity grading methodology
- CAPA systems, complaint handling, internal audits, and advisory notice reporting
- Design and development controls, risk management, and supplier management processes
- Production and process controls including validation, traceability, sterilization, and software validation
- Regulatory reporting requirements across FDA, TGA, ANVISA, Health Canada, and MHLW
- Practical auditing skills through workshops, mock audits, and scenario-based exercises.
Day 1: Foundations of Auditing & Audit Framework
- Introduction to auditing principles and methodologies
- Audit concepts based on ISO 19011:2018
- Auditor roles, competency requirements, and professional behaviour
- Audit scope, criteria, and audit planning
- Checklist preparation and evidence collection techniques
- Conducting opening and closing meetings
- Non-conformity writing and audit reporting
- Audit follow-up activities and practical exercises
Day 2: MDSAP Fundamentals & Management Processes
MDSAP Fundamentals
- Goals and objectives of MDSAP
- MDSAP versus ISO 13485 audits
- Participating regulatory authorities and stakeholders
- MDSAP audit model and audit sequence
- Non-conformity grading and reporting systems
Chapter 1 – Management Processes
- Quality management system planning
- Quality manual and documentation controls
- Change management processes
- Management review and responsibilities
- Outsourced process controls and competency management
Chapter 2 – Device Marketing Authorization & Facility Registration
- Regulatory registration processes
- Device authorization requirements
- QMSR requirements and practical exercises
Day 3: Measurement, Analysis & Improvement (MAI) and Design Controls
Chapter 3 & 4 – MAI and Advisory Notices Reporting
- CAPA systems and complaint handling
- Internal audits and non-conformance management
- Adverse event and advisory notice reporting requirements
- Regulatory reporting expectations for:
- FDA (USA)
- Health Canada
- ANVISA (Brazil)
- TGA (Australia)
- MHLW (Japan)
Chapter 5 – Design & Development
- Design control processes
- Risk management integration
- QMSR requirements
- Checklist preparation exercises and quizzes
Day 4: Production & Purchasing Controls
Production and Service Controls
- Production process controls and infrastructure requirements
- UDI planning and traceability
- Process validation and software validation
- Sterilization process validation
- Monitoring and measurement of product conformity
- Device master records and documentation requirements
Purchasing Controls
- Supplier selection and evaluation
- Supplier monitoring and control processes
- Purchased product verification activities
- Practical exercises and checklist preparation
Day 5: Workshops, Mock Audits & Final Examination
- Audit scope and criteria definition exercises
- Audit plan creation workshop
- Mock audits using industry-relevant scenarios
- Practical audit simulations
- Final qualification examination
- Quality Assurance (QA) professionals
- Regulatory Affairs (RA) professionals
- Medical device auditors and lead auditors
- Clinical research and clinical operations professionals
- Design and development engineers
- Manufacturing and production professionals
- Supplier quality and process owners
- Research & Development professionals
- Compliance managers and consultants
- Professionals preparing for MDSAP or FDA inspections
- Participants are required to complete a pre-course eligibility quiz with a minimum passing score before the start of the training.
- Basic understanding of quality management systems and medical device regulations is recommended.
- Participants are recommended to have relevant industry experience in medical devices, quality, regulatory affairs, manufacturing, or engineering functions.
- Formal educational qualifications such as Diploma, bachelor’s degree, or equivalent is preferred.
This programme helps professionals strengthen their expertise in medical device regulatory compliance and auditing practices aligned with globally recognized standards. Participants gain practical auditing capabilities that support organizational compliance, regulatory readiness, and quality system improvement initiatives.
Key Benefits:
- Build competency in MDSAP and FDA QMSR auditing
- Enhance professional credibility with globally recognized certification
- Develop practical skills for conducting first, second, and third-party audits
- Improve understanding of international medical device regulatory requirements
- Strengthen audit preparedness and compliance management capabilities
- Support career growth in QA/RA, compliance, and auditing functions
- Gain practical exposure through workshops and mock audits
Participants are evaluated through continuous assessment activities conducted throughout thetraining programme along with a final online examination. Classroom exercises, workshops, and scenario-based activities form part of the continuous evaluation process.
Examination Details:
- Examination mode: Online
- Question format: Scenario-based multiple-choice questions
- Exam duration: 120 minutes
- Passing criteria: Minimum 70%
- Continuous evaluation submission is mandatory
Participants who successfully complete the continuous evaluation and final examination will be awarded the MDSAP and QMSR Lead Auditor Certification by TÜV SÜD South Asia.
1. What is the difference between MDSAP and ISO 13485 audits?
MDSAP audits evaluate compliance with both ISO 13485 and additional regulatory requirements of participating countries, whereas ISO 13485 audits primarily focus on quality management system compliance.
2. Which countries participate in the MDSAP programme?
The participating regulatory authorities include:
- United States FDA
- Health Canada
- ANVISA (Brazil)
- TGA (Australia)
- MHLW/PMDA (Japan)
3. What is FDA QMSR?
FDA QMSR (Quality Management System Regulation) is the updated FDA quality system framework designed to align more closely with ISO 13485 while maintaining FDA regulatory requirements for medical devices.
4. Does the course include practical audit exercises?
Yes. The programme includes checklist preparation, mock audits, audit planning workshops, case studies, and scenario-based exercises to provide hands-on auditing experience.
5. Will participants learn MDSAP non-conformity grading methodology?
Yes. Participants will learn how non-conformities are classified, graded, documented, and reported according to MDSAP requirements.
6. Is risk management covered in the training?
Yes. The course includes risk management concepts related to design controls, CAPA systems, product safety, and audit evaluations within medical device quality management systems.
7. How does this training help during regulatory inspections?
The training help organizations improve audit readiness, strengthen compliance processes, identify quality system gaps, and prepare effectively for regulatory inspections and certification audits.
8. What happens if a participant fails the final examination?
Participants are generally permitted an additional examination attempt as per TÜV SÜD certification policies. Details regarding re-examination procedures and applicable fees are shared during the training process.
9. What is the mode of this course?
The course is available in either modes: classroom or virtual.
10. Is VILT a live training, or do I get access to watch pre-recorded videos?
This is a live virtual instructor-led training (VILT) session where you can interact with the trainer.
Pre-recorded videos are not available or permitted.
11. Can the dates of the training be customized?
The training dates are published in advance, although you may let us know your preferred dates for exclusive training by mailing us on [email protected].
12. Is there a refund policy for the course fees?
Yes, refund details are governed by the Cancellation and Refund Policy. Participants are advised to refer to the official policy page for complete information.