ISO 13485:2016 Lead Auditor Training Program for Medical Devices with FDA QMSR & MDSAP Regulatory Requirements (USA/Canada) — 2026 Update
This Exemplar Global–certified 5‑day Lead Auditor Training Program provides participants with the competence to perform first‑, second‑, and third‑party audits of Medical Device Quality Management Systems (MD‑QMS) according to ISO 13485:2016 and applicable global regulatory requirements in alignment with ISO 19011 and ISO/IEC 17021.
The training now includes a dedicated regulatory module on the 2026 North America update — ISO 13485 with FDA QMSR (USA/Canada) — covering the modernization of 21 CFR Part 820 into the FDA Quality Management System Regulation (QMSR) effective February 2, 2026, and its alignment with ISO 13485:2016. Participants also learn how the Canadian CMDR and MDSAP requirements integrate with ISO 13485 and how these impact audit planning, execution, and reporting. This new module provides essential insights for auditors working with manufacturers operating in the U.S. and Canadian markets.
Learners gain an in‑depth understanding of MD‑QMS regulatory expectations, including risk‑based QMS processes, lifecycle documentation via the Medical Device File (MDF), UDI, complaint handling, PMS obligations, vigilance, labeling requirements, and unique retained U.S. regulatory elements (MDR 803, Corrections & Removals 806, Tracking 821).
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
The ISO 13485 Lead Auditor certification training course can be attended by medical device quality testing professionals interested in conducting first-party, second-party, and third-party audits.
- Management representatives.
- Quality directors, managers, and engineers.
- Consultants.
1) MD-QMS Introduction and Process Approach
- Purpose and benefits of MD-QMS-Requirements for Regulatory Purposes including understanding of the basic MD-QMS principles
- Terms, Fundamentals and Principles
- Process Approach with PDCA
- Mandatory documents for regulatory purposes
- Difference between compliance and conformance
- Relationship between IMDRF and GHTF
- Principles of IMDRF
- MDR European Union Regulations
- MD-QMS Requirements (Clause 1 to 8)
1.5) ISO 13485 with FDA QMSR (USA/Canada) 2026 Update — NEW MODULE
- FDA modernization of 21 CFR 820 into QMSR (effective Feb 2, 2026)
- ISO 13485 incorporation and remaining FDA‑specific requirements (UDI 830, MDR 803, C&R 806, Tracking 821)
- Transition to the Medical Device File (MDF) replacing DMR/DHF/DHR
- North America regulatory comparison: FDA QMSR vs CMDR/MDSAP — audit implications
- Canadian licensing (MDL / MDEL), bilingual labeling, PMS/incident reporting, and MDSAP audit expectations
- Internal audit considerations under QMSR & MDSAP
- Traceability expectations under design (7.3) and production (7.5.8/7.5.9) controls
2) Auditing Principle
- Auditing objectives
- Types of audits
- Audit life cycle
- Terms and Definition
- Principle of Auditing
- Annex A – Guidance of Auditors
3) Role and Responsibilities of Auditor
- Audit Programme objectives
- The auditees responsibilities
- The lead auditors’ responsibilities
- Auditors qualification and certifications
4) Role Planning an Audit
- Pre-Audit planning
- Reviewing documentation
- Developing an audit plan
- Preparing checklists or working documents
- Communication factors
5) Conducting an Audit
- Opening meeting
- Collecting objective/audit evidence
- Effective interviewing techniques
- Identifying and recording nonconformities
- Preparing for the closing meeting
6) Reporting Audit Results
- Conducting the closing meeting
- Preparing the audit report
- Distributing the audit report
7) Corrective Actions
- Corrective action responsibilities
- Follow up scheduling
- Monitoring corrective action
8) ISO 13485: 2016 Registration
- The registration processes
- Surveillance audits
9) Exercises/ Role play (50 % of course Time)
10) Written Examination
Upon successful completion of this course and its examination, delegates will be able to:
Knowledge Outcomes
- Explain the purpose of a Medical Device Quality Management System and its relationship to global regulatory authorities.
- Describe ISO 13485:2016 requirements and their alignment with FDA QMSR and CMDR/MDSAP expectations.
- Understand the role of an auditor in planning, conducting, reporting, and following up on MD‑QMS audits in accordance with ISO 19011 and ISO/IEC 17021.
Skills Outcomes
- Plan, conduct, report, and follow up an audit of an MD‑QMS to establish conformity with ISO 13485:2016 and applicable regulatory requirements (FDA QMSR, CMDR/MDSAP).
- Apply risk‑based auditing, evaluate lifecycle documentation (including MDF), and assess regulatory compliance evidence for North American markets.
This intensive and participative Lead Auditor program uses case studies, workshops, role‑plays, and group activities to build practical auditing capability and ensure learners can confidently perform and lead MD‑QMS audits globally.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:
- Access to Exemplar LINK
- 12-months of exclusive benefits including:
- One self-coaching assessment
- Extended learning content
- Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
- Access to an exclusive LinkedIn Community
- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.
Learn more about TÜV SÜD's Exemplar Global Accreditation today
This is an instructor-led training in a virtual classroom. There is a balance between knowledge-based presentation, discussions, exercises and case studies. 50% of the time is spent on activity-based learning.
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
In order to satisfactorily complete the course each trainee must:
1. Complete/attend all elements of the course.
2. Pass the continuous assessment.
3. Pass the written examination.
Evaluation parameters
1) Continuous Assessment: Punctuality, presentation skills, interactive approach, involvement, role-play, daily tests etc.
2) Written examination: (Closed book) at the end of the course.
- Participants who score 70% and above in both the continuous assessment and written examination will be issued a certificate of successful completion of the course. The Lead Auditor course is made in line with international registers and guidelines.
- Unsuccessful candidates will be issued a certificate of attendance.
Learners must obtain a copy of the ISO standard to be referenced during the course. The standard may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
As the ISO 13485 Lead Auditor training covers auditing concepts utilising ISO 13485, a prior understanding of ISO 13485 and its implementation within a Medical Device business and internal audit experience is recommended.
MD -QMS
- MD -QMS Terms and definitions
- MD -QMS Requirements
- ISO 9000 – Terms and Definitions
Other related standards
- IEC 62304
- PD ISO/TR 80002-2-2017
- IEC/ISO60601
- ISO14937
- ISO14644
- 14698-1
Relationship With
- GHTF
- IMDRF
- MDSAP