This is not passive learning — you will work actively throughout all three days on real audit scenarios.

The entire training is interactive and workshop-based.
There is no separate “practical day” — the whole course is practical.

Day 1: Audit fundamentals & Regulatory context (interactive workshop)

• Introduction & overview of the training program
• ISO 13485 in the context of MDR / IVDR and CE marking
• Overview of conformity assessment routes (incl. modules D, E, H)
• Relationship with FDA (21 CFR Part 820) and ISO 9001
• Audit principles and methodology (ISO 19011)
• Risk-based audit planning

Workshop exercises:

• Formulating audit questions
• Practicing interview techniques
• Evaluating audit evidence based on real examples
• Audit preparation and opening meeting simulation

Day 2: Audit execution in practice (interactive workshop)

• Performing internal audits in real-life situations
• Auditing key ISO 13485 requirements in practice
• Focus areas:
• design & development
• purchasing
• production
• customer-related processes

Workshop exercises:

• Document audit (procedures & records)
• Identifying nonconformities
• Writing professional audit findings
• Practicing audit communication

Day 3: Integrated audit workshop & closing (interactive workshop)

Participants work through a complex, realistic audit scenario combining all previous knowledge.

• Auditing additional key processes:
• monitoring & measurement
• control of nonconforming products
• data analysis and improvement

Workshop exercises:

• Audit interview simulation
• Complex document audit
• Identifying and structuring nonconformities
• Audit reporting (evaluation and communication of findings)
• Closing meeting simulation

Includes final exam (short theoretical test)

By the end of the training, you won’t just understand auditing. You will be able to think and decide like an auditor.

The training is built on multiple complementary learning materials:

• Structured professional content with more than 500 slides, covering ISO 13485 requirements and the full audit lifecycle
• A practical exercise package based on real audit scenarios
• Separate digital learning material that processes ISO 13485 requirements in a detailed and structured way

Structure of the digital learning material

• The digital material presents the requirements of the ISO 13485 standard in a logical, modular structure, including implementation examples.

Main topics:

• Fundamentals and interpretation of the standard
  • scope, terminology, references
• Quality Management System (QMS)
  • system structure and operation
• Management responsibility
  • roles, responsibilities, governance
• Resource management
  • competencies, infrastructure, environment
• Full product realization process
  • design and development
  • customer-related processes
  • purchasing
  • production and service provision
  • detailed breakdown of process steps
• Control of monitoring and measuring equipment
• Measurement, analysis and improvement
  • monitoring and measurement
  • control of nonconforming product
  • data analysis
  • continuous improvement
• Connection to MDR requirements
  • relationship between ISO 13485 and MDR quality management expectations

The material does not only present the requirements, but supports practical understanding through concrete implementation examples.

The full training material covers:

• the entire audit process (from planning to closure)
• audit aspects of the CE marking process
• alignment with MDR / IVDR requirements

The digital learning material remains accessible for more than 6 months after the training (until December 31, 2026), allowing participants to revisit specific topics later.

The knowledge gained is directly applicable in daily work — not only as an auditor, but also in operating and improving the quality management system.

The training concludes with an online multiple-choice exam designed to assess participants’ understanding of ISO 13485 and internal auditing principles.

Exam format

The exam includes questions covering:

• ISO 13485 requirements
• audit principles and methodology
• key concepts discussed during the training

The purpose is to verify that participants have understood the core concepts and can apply them in practice.

Evaluation

• the exam result is expressed as a percentage
• a minimum score of 70% is required to obtain the certificate

Outcome

The exam confirms that the participant has acquired the necessary knowledge to support internal auditing activities in an ISO 13485 environment.

Participants who successfully pass the exam will receive an ISO 13485 Internal Auditor Certificate

The certificate confirms that the participant:

• is capable of planning internal audits according to ISO 13485
• is capable of performing audits
• is capable of professionally formulating audit findings

What does this mean in practice?

The certificate confirms that the participant:

• is prepared to take on the role of an internal auditor;
• is able to conduct audits independently within their organization;
• can confidently participate in preparation for certification audits.

Important note

The certificate:

• confirms internal auditor competence;
• does not constitute certification body or regulatory authorization;
• does not replace a certification audit.

The goal of the training is that participants complete the program with real, applicable auditing knowledge that they can use immediately within their own organization.

Csaba Sántics
Consultant, Trainer, Auditor

He has more than 20 years of experience in the design, operation, and auditing of quality management systems.

In recent years, his work has primarily focused on:

• development and auditing of ISO 13485 systems
• supporting the CE marking process of medical devices
• practical implementation of MDR / IVDR requirements

During his work, he is regularly involved in:

• conducting internal and supplier audits
• preparing organizations for international audits
• developing quality management systems

During the training, you will gain not only theoretical knowledge, but also a practical, experience-based mindset that can be directly applied within your own organization.

Limited-time discount

15% Super Early Bird discount (until May 25, 2026)
€ 978 instead of € 1,150 / person
(excluding VAT, if applicable)

Other discounts

Group discount

If multiple participants register from the same company, the following discounts apply from the list price:

• 2 participants: 5% discount
• 3 participants: 10% discount
• 4 or more participants: 15% discount

Alumni discount (for individuals)

• If you have previously attended a training by NoBoVersum or SAASCO Medical, a 15% discount is applied to the list price.

Important information

• Periodic and other discounts cannot be combined.
• In all cases, the most favorable (highest-value) discount will be applied.
• The participation fee is payable by bank transfer based on the issued invoice.
• The participation fee does not include applicable VAT.
• The number of places is limited; registrations are accepted on a first-come, first-served basis.
• We reserve the right to make changes.