MDR Medical Device Conformity Assessment Training
Practice-Oriented Training for Future Site Auditors, Product Reviewers, Clinical Experts and Manufacturers in MDR Conformity Assessments
Course Duration:
Site Auditor Group: Feb. 6, 2025 – Dec. 4, 2025
Product Reviewer Group: Feb. 6, 2025 – Nov. 28, 2025
Clinical Expert Group: Feb. 6, 2025 – Nov. 26, 2025
The exact dates of the in-person sessions can be found in the description of the supplementary modules. Online participation is available upon request.
Application Deadline: February 4, 2025
Location of the in-person sessions:
1134 Budapest, Váci út 49, 6th Floor
Course Fee:
See Details.
Attention! The training is currently available only in Hungarian. To apply, please visit the Hungarian site.
Current Relevance
The rapid development of technology and the potential for varying interpretations of previous regulations have contributed to the European Union’s move to stricter and more unified regulations for the conformity assessment of medical devices. This led to the creation of the new regulation for medical devices. However, many provisions of the MDR raise significant legal interpretation questions. Furthermore, the full capacity of organizations dealing with MDR conformity assessments is still insufficient. Therefore, NoBoversum is launching a unique, intensive 10-month training program!
Our hybrid training, consisting of practical project tasks and online learning materials, aims to prepare manufacturers and future site auditors, product reviewers, clinical experts for all tasks related to MDR conformity assessments of medical devices.
Details
Item number: 8000/02
Training Format: Blended training
Blended training is a hybrid educational form that combines e-learning opportunities and traditional classroom education. The MDR Medical Device Conformity Assessment Training primarily takes place online, with practical group project tasks conducted through in-person sessions.
Training structure:
The MDR Medical Device Conformity Assessment core module consists of six base subjects.
In addition to the core module, participants can choose from three supplementary modules: Site Auditor, Product Reviewer, or Clinical Expert, with at least one being mandatory.
Instructors
- Ákos Csizmár (Medical Gas Application Engineer, Linde Gas Hungary Ltd.)
- Andrea Baisánszki (Quality Specialist, EMKI-cert Medical Device Certification Ltd.)
- Árpád Zsolt Bús (Consultant and Test Engineer, SAASCO Consulting and Engineering Office Ltd.)
- Attila Juhász (Professional Lead, SAASCO Consulting and Engineering Office Ltd.)
- Csilla Pozsgay MD. (Chairperson, NoBoMed Ltd.)
- György Balázs (Managing Director, Quality Expert, EMKI-cert Ltd.)
- Judit Kántor (Trainer)
- Katalin Taubné Jakab, MD. (Clinical Expert, QTICS Medical)
- László Németh MD., Ph.D. (Surgeon, Pediatric Surgeon, Specialist)
- Mária Kriston (Professional Lead, Site Auditor, NoBoMed Plc.)
- Mihály Dió Ph. D. (Assistant Professor, Semmelweis University)
- Péter Zombory (Electrical Engineer, Hospital and Medical Device Engineer, National Korányi Pulmonology Institute)
- Tímea Markóné Németh (Quality Expert, EMKI-cert Medical Device Certification Ltd.)
- Zoltán Péter Ackermann (Managing Director, Minel Ltd.)
- Zsolt Horváth Ph.D. (Managing Director, CEMDS Ltd.)
- This training is recommended for those considering a career as a medical device certifier within a notified body. Through our program, participants can gain insights into the intricacies of a highly sought-after and respected profession.
- The training is also recommended for medical device manufacturers who want to understand what to expect during the certification process and how to prepare effectively for such an audit.
- The main task of a site auditor is to carry out audits of the manufacturer’s quality management system at the site of the manufacturing company. This includes conducting interviews with the manufacturer’s employees and inspecting various processes.
| REQUIREMENTS FOR BECOMING A SITE AUDITOR (MDR Annex VII, Section 3.2.6) | |
| Required qualification: | Required Professional Experience: |
| Relevant university or technical college degree (e.g., in medical, pharmaceutical, engineering, or other relevant fields) or equivalent qualification. | 4 years of professional experience in the field of healthcare products or related activities (e.g., manufacturing, auditing, or research), including 2 years in quality management. |
- A product reviewer is responsible for reviewing the medical device itself. This primarily involves assessing whether the product’s technical documentation complies with legal and standard requirements.
| REQUIREMENTS FOR BECOMING A PRODUCT REVIEWER (MDR Annex VII, Section 3.2.5) | |
| Required qualification: | Required Professional Experience: |
| Relevant university or technical college degree (e.g., in medical, pharmaceutical, engineering, or other relevant fields) or equivalent qualification. | 4 years of professional experience in the field of healthcare products or related activities (e.g., manufacturing, auditing, or research), including at least 2 years in the design, development, testing, or use of medical devices, or in the relevant technology or scientific aspects being evaluated. |
- A clinical expert evaluates the product’s compliance from a clinical perspective. This includes reviewing clinical evaluations conducted by the manufacturer and examining data from any clinical trials.
| REQUIREMENTS FOR BECOMING A CLINICAL EXPERT (MDR Annex VII and NBOG’s BPG 2017-2, Section 5.4) | |
| Required qualification: | Required Professional Experience: |
| The MDR does not specify exact qualifications. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. | The MDR does not specify exact professional experience. However, the related Guide (NBOG 2017-2) generally expects a medical qualification. The MDR/IVDR does not specify the necessary professional experience either. According to the related Guide (NBOG 2017-2), the following is required:
|
Duration: 10 months
The training is on break during July and August.
Participants still have access to the e-learning materials during this period.
Dates:
- Core Module + Site Auditor Supplementary Module: February 6, 2025 (Thursday) – December 4, 2025 (Thursday)
- Core Module + Product Reviewer Supplementary Module: February 6, 2025 (Thursday) – November 24, 2025 (Friday)
- Core Module + Clinical Expert Supplementary Module: February 6, 2025 (Thursday) – November 6, 2025 (Wednesday)
Application Deadline: February 4, 2025
Attention! The dates of individual in-person training sessions – i.e., the practical projects – can be found in the descriptions of the supplementary modules. We reserve the right to change the dates.
Training Fees:
Core MDR Module Fee*: 1,000,000 HUF per person
Supplementary Module Fees* (at least one supplementary module is required):
- Site Auditor: 850,000 HUF per person
- Product Reviewer: 650,000 HUF per person
- Clinical Expert: 650,000 HUF per person
The module fees include the following items:
- Tuition Fee: Includes access to the e-learning platform and catering during in-person sessions.
- Exam Fee: Covers the cost of the expert instructor-administered exam and evaluation based on personal attendance, as well as the issuance of a certificate upon successful completion.
The payment schedule for the training fee is as follows:
Deadline for the first part transfer: February 14, 2025.
Deadline for the second part transfer: July 7, 2025.
* The fees for both the core module and the supplementary modules are exempt from VAT based on Section 85 (2) (bb) of Act CXXVII of 2007 on Value Added Tax, as the course is organized under an adult education license.
The training fee does not include the fee for any retake exams, which is 100,000 HUF per person per retake exam.
In-person sessions location: 1134 Budapest, Váci út 49. 6th Floor
Online participation is available upon request.
The training consists of two main parts:
- THEORETICAL PART – Online Learning via a Modern E-learning Platform
✔ The theoretical knowledge is acquired by participants through smaller digital units, known as learning molecules, which are adaptable to the individual knowledge and learning pace of the participants.
✔ Each molecule is linked to a practical online test, which helps integrate the knowledge into long-term memory.
✔ The e-learning platform allows for adaptive teaching. If a participant already knows a specific topic, they can skip it by successfully completing a short online test. This way, everyone learns only what they truly need!
- PRACTICAL PART –Practical Group Project Tasks in a Group conducted through In-Person Sessions
✔ During in-person sessions, participants work in groups to solve project tasks assigned by an expert mentor.
✔ The mentor continuously supervises and supports the participants’ work: assigns tasks to group members and provides ongoing consultation opportunities. The participants’ performance is evaluated in a formative manner through continuous feedback integrated into the learning process.
✔ What types of project tasks should be anticipated? Tasks that are commonly encountered in the role of a site auditor, a product reviewer or a clinical expert! For example, a future site auditor will likely need to plan audits, identify so-called non-conformities or prepare various audit reports. Thus, it is understandable that the course will include such project tasks.
✔ Because it provides marketable, practical, and up-to-date knowledge!
Our modern training program was developed in response to the real labour market needs of the medical technology industry. We identified the tasks that future site auditors, product reviewers, and clinical experts will need to perform in their new roles. These activities were then translated into practical project tasks.
✔ Because it is adaptive, catering to participants’ varying qualifications and knowledge levels!
Our goal is for participants not to spend unnecessary time on knowledge they already possess. This is achieved through our platform’s “synthesizing molecules.” These molecules test knowledge in specific areas through an online quiz. If participants successfully complete the quiz, they can skip the corresponding learning modules related to that topic.
✔ Because the molecular educational method helps in understanding logical connections!
The essence of the molecular educational method is to organize theoretical knowledge into the smallest, independently understandable units, known as learning molecules. Participants who are balancing the course with work can more easily find time to master these smaller units. Additionally, logically structured knowledge molecules aid in understanding more complex connections.
✔ Because it can be completed alongside work!
A modern adult education program must be feasible alongside a full-time job. An online or hybrid training format – combining classroom and online instruction – offers the flexibility for participants to progress through the material at their own pace and according to their own schedule.
✔ Because we focus on skill development rather than just knowledge transfer!
Participants must collaboratively solve and present practical project tasks to mentors. This process helps in developing various skills, such as teamwork, problem-solving, and communication.
✔ Upon a successful exam, participants will receive not only a certificate from the Hungarian Adult Education Authority (FAR) but also a certificate issued by NoBoVersum in both Hungarian and English.
✔ The certificate issued by NoBoVersum verifies that the participant who successfully completes the training possesses all the knowledge required by Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR) for site auditors, product reviewers, or clinical experts of notified bodies.
✔ NoBoVersum’s own certificate includes a detailed list of the theoretical subjects and their durations, as well as the practical project tasks.
Training Structure
I. Core Module (for all participants)
- General Knowledge of MDR (Subject Code: MB001, Author: Attila Juhász)
- Clinical Evaluation of Medical Devices (Subject Code: MB002, Author: Tímea Markóné Németh)
- Biological Evaluation of Medical Devices (Subject Code: MB003, Author: Dr. Zsolt Horváth)
- MDR General Safety and Performance Requirements (GSPR) (Subject Code: MB004, Author: György Balázs)
- MDR Conformity Assessment Procedures (Subject Code: CB001, Author: Attila Juhász)
- Basics of Risk Management (Subject Code: CB002, Author: Attila Juhász)
Participants are required to complete at least one of the following subjects.
- Active, Non-Implantable Medical Devices and Their Basic and Supplementary Harmonized Standards and Specifications (Subject Code: MH001, Author: Árpád Zsolt Bús)
- Ionizing Radiation-Based Non-Implantable Imaging Devices and Their Harmonized Standards and Specifications (Subject Code: MH002, Author: Krisztián Fábián)
- Non-Ionizing Radiation-Based Active, Non-Implantable Imaging Devices and Their Harmonized Standards and Specifications (Subject Code: MH003, Author: Krisztián Fábián)
- Vital Signs Monitoring Devices and Their Harmonized Standards and Specifications (Subject Code: MH004, Authors: Árpád Zsolt Bús, Dr. Mihály Dió)
- Hyperthermia/Hypothermia Devices and Their Harmonized Standards and Specifications (Subject Code: MH005, Author: Dr. László Németh)
- Active, Non-Implantable Devices for Stimulation or Inhibition and Their Harmonized Standards and Specifications (Subject Code: MH006, Authors: Zoltán Ackermann, Dr. Mihály Dió, Dr. László Németh)
- Active, Non-Implantable Devices for Extracorporeal Circulation, Material Administration or Removal, and Hemopheresis, and Their Harmonized Standards and Specifications (Subject Code: MH007, Author: Dr. László Németh)
- Active, Non-Implantable Respiratory Support Devices and Their Harmonized Standards and Specifications (Subject Code: MH008, Author: Péter Zombory)
- Other Active, Non-Implantable Surgical Devices and Their Harmonized Standards and Specifications (Subject Code: MH009, Author: Dr. László Németh)
- Medical Gas Supply Systems and Their Components, and Their Harmonized Standards and Specifications (Subject Code: MH010, Authors: Ákos Csizmár, Péter Zombory)
- Non-Implantable Devices for Cleaning, Disinfection, and Sterilization, and Their Harmonized Standards and Specifications (Subject Code: MH011, Author: Dr. László Németh)
- Non-Active Cardiovascular and Neurovascular Implants and Their Harmonized Standards and Specifications (Subject Code: MH012, Author: Dr. László Németh)
- Non-Active Bone and Orthopedic Implants and Their Harmonized Standards and Specifications (Subject Code: MH013, Author: Dr. László Németh)
- Introduction to the training goals, educational methodology, and use of the e-learning platform. Meet the mentors for the practical project tasks and other participants in the training.
- Date: February 6, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
II. Supplementary Modules (required to choose at least one)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for site auditors
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Quality Management Systems and Auditing Techniques (Subject Code: CR002, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
- Communication (Subject Code: MR004, Author: Judit Kántor)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Review of Manufacturer’s Documents
- The goal of this project is to enable the participant to critically review the documents submitted by the manufacturer (e.g., technical drawings, manufacturer’s manual).
- Date: March 6, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 2: Preparing an Audit Plan Based on the Provided Documents
- By the end of the project, the participant will be able to independently plan on-site audits based on the manufacturer’s quality management documents.
- Date: March 27, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 3: Communication and Assertiveness in Practice. On-site Inspection Simulation I
- In the first part of the project, participants will practise the appropriate communication management of different situations that may occur during on-site audits. In the second part of the project participants will simulate audit situations.
- Date: April 10, 2025 (Thursday)
- Instructor, mentor: Judit Kántor, Mária Kriston
Project 4: Non-conformity Report I
- The aim of the project is to enable the participant to be able to independently record the non-compliances detected during on-site audits.
- Date: April 24, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 5: On-site Inspection Simulation II
- The project aims to simulate more difficult or critical situations that may arise during audits, followed by an appropriate assessment and successful resolution of these situations.
- Date: May 8, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 6: Non-conformity Report II
- The aim of the project is to enable the participant to be able to independently record the non-compliances detected during on-site audits.
- Date: May 22, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 7: Unannounced Audit
- The project aims to prepare the participant for resolving spontaneous situations that may arise during unannounced audits.
- Date: September 18, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 8: Evaluation of the Manufacturer’s Quality Management Documentation for the Production Process
- By the end of the project, the participant will be capable of critically reviewing and evaluating the manufacturer’s submitted documentation and determining whether the client is ready for an on-site audit.
- Date: October 9, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 9: Preparing an Audit Report I
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: October 30, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 10: Preparing an Audit Report II
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: November 20, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
ON-SITE EXAM
Preparing an Audit Report
Date: December 4, 2025 (Thursday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for product reviewers
- Clinical Evaluation of MD Medical Devices (Subject Code: MR001, Author: Dr. Katalin Tauberné Jakab)
- MDR Technical Documentation Assessment (Subject Code: MR002, Author: Andrea Baisánszki)
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Summary of MDR Technical Documentation Assessment Sections
- By the end of the project, the participant will be able to plan and execute a critical review of technical documentation in a conformity assessment project.
- Date: February 28, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 2: Preparing a Technical Documentation Checklist (with document review task)
- By the end of the project, the participant will be able to identify the legal requirements relevant to the topic.
- Date: March 28, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 3: Preparing a GSPR Compliance Checklist (with document review task)
- By the end of the project, the participant will be able to create a report on the manufacturer’s general safety and performance requirements and gather relevant information following the necessary criteria.
- Date: April 25, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 4: Creating a Validation Plan
- By the end of the project, the participant will be able to determine when validation is necessary and assess the quality of the validations received during the technical documentation review.
- Date: May 16, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 5: Evaluation of Manufacturer-Provided Documents (Instructions for Use and Labelling)
- By the end of the project, the participant will be able to critically evaluate the documents provided by the manufacturer.
- Date: June 13, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 6: Creating a Risk Assessment
- By the end of the project, the participant will be able to process and synthesize legal requirements and critically evaluate the risk management documentation.
- Date: September 19, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 7: Technical Documentation Evaluation I
- By the end of the project, the participant will be able to critically evaluate technical documentation.
- Date: October 17, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 8: Technical Documentation Evaluation II
- By the end of the project, the participant will be able to critically evaluate technical documentation.
- Date: November 14, 2025 (Friday)
- Instructor, mentor: Attila Juhász
ON-SITE EXAM
Evaluation of Technical Documentation
Date: November 28, 2025 (Friday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for clinical experts
- Clinical Evaluation of MD Medical Devices (Subject Code: MR001, Author: Dr. Katalin Tauberné Jakab)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Summary of Clinical Evaluation Requirements
- By the end of the project, the participant will be able to identify and summarize the clinical evaluation requirements based on the MDR and other relevant regulations.
- Date: March 5, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 2: Planning a Clinical Evaluation According to the Law
- By the end of the project, the participant will be able to plan a clinical evaluation considering relevant legal requirements and guidelines, including determining the necessary resources and methods.
- Date: March 26, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 3: Collecting Documentation and Literature
- By the end of the project, the participant will be able to effectively gather and organize the necessary documentation and relevant literature for clinical evaluation, ensuring the reliability and legal compliance of the sources.
- Date: April 16, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 4: Evaluation and Screening of Literature with Justification
- By the end of the project, the participant will be able to critically evaluate and screen the collected literature, justifying the selection of relevant and reliable sources for clinical evaluation.
- Date: May 14, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 5: Reflection on the Statistical and Methodological Content of the Filtered Literature
- By the end of the project, the participant will be able to reflect on and critically analyze the statistical analyses and other methodological elements of the filtered literature, assessing the validity of the conclusions.
- Date: June 18, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 6: Designing a Clinical Trial
- By the end of the project, the participant will be able to plan a clinical trial, including developing the study protocol, determining the experimental design, and identifying the necessary resources and methods for the trial’s execution.
- Date: September 24, 2025 (Wednesday)
- Instructor, mentor: Péter Hársfalvi
Project 7: Conducting a Clinical Evaluation
- By the end of the project, the participant will be able to conduct a clinical evaluation based on the predetermined plan and methodology, including data collection, analysis, and interpretation in compliance with legal requirements.
- Date: October 15, 2025 (Wednesday)
Project 8: Preparing a Clinical Evaluation Review Report Based on the Relevant MDCG Guide (CEAR)
- By the end of the project, the participant will be able to prepare a clinical evaluation review report based on the relevant MDCG (Medical Device Coordination Group) guidelines, ensuring the report’s completeness and legal compliance.
- Date: November 12, 2025 (Wednesday)
ON-SITE EXAM
Review of Clinical Evaluation
Date: November 26, 2025 (Wednesday)
II. Supplementary Modules (required to choose at least one)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for site auditors
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Quality Management Systems and Auditing Techniques (Subject Code: CR002, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
- Communication (Subject Code: MR004, Author: Judit Kántor)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Review of Manufacturer’s Documents
- The goal of this project is to enable the participant to critically review the documents submitted by the manufacturer (e.g., technical drawings, manufacturer’s manual).
- Date: March 6, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 2: Preparing an Audit Plan Based on the Provided Documents
- By the end of the project, the participant will be able to independently plan on-site audits based on the manufacturer’s quality management documents.
- Date: March 27, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 3: Communication and Assertiveness in Practice. On-site Inspection Simulation I
- In the first part of the project, participants will practise the appropriate communication management of different situations that may occur during on-site audits. In the second part of the project participants will simulate audit situations.
- Date: April 10, 2025 (Thursday)
- Instructor, mentor: Judit Kántor, Mária Kriston
Project 4: Non-conformity Report I
- By the end of the project, the participant will be able to independently record non-conformities identified during on-site audits.
- Date: April 24, 2025 (Thursday)
- Instructor, mentor: Attila Juhász
Project 5: On-site Inspection Simulation II
- The project aims to simulate more difficult or critical situations that may arise during audits, followed by an appropriate assessment and successful resolution of these situations.
- Date: May 8, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 6: Non-conformity Report II
- By the end of the project, the participant will be able to independently record non-conformities identified during on-site audits.
- Date: May 22, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 7: Unannounced Audit
- The project aims to prepare the participant for resolving spontaneous situations that may arise during unannounced audits.
- Date: September 18, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 8: Evaluation of the Manufacturer’s Quality Management Documentation for the Production Process
- By the end of the project, the participant will be capable of critically reviewing and evaluating the manufacturer’s submitted documentation and determining whether the client is ready for an on-site audit.
- Date: October 9, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 9: Preparing an Audit Report I
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: October 30, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
Project 10: Preparing an Audit Report II
- By the end of the project, the participant will be able to process, evaluate, and document the findings gathered during an audit.
- Date: November 20, 2025 (Thursday)
- Instructor, mentor: Mária Kriston
ON-SITE EXAM
Preparing an Audit Report
Date: December 4, 2025 (Thursday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for product reviewers
- Clinical Evaluation of MD Medical Devices (Subject Code: MR001, Author: Dr. Katalin Tauberné Jakab)
- MDR Technical Documentation Assessment (Subject Code: MR002, Author: Andrea Baisánszki)
- Design for Good Usability (Subject Code: CR001, Author: Attila Juhász)
- Validation (Subject Code: MR003, Authors: Mária Kriston, Róbert Heck, György Balázs)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Summary of MDR Technical Documentation Assessment Sections
- By the end of the project, the participant will be able to plan and execute a critical review of technical documentation in a conformity assessment project.
- Date: February 28, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 2: Preparing a Technical Documentation Checklist (with document review task)
- By the end of the project, the participant will be able to identify the legal requirements relevant to the topic.
- Date: March 28, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 3: Preparing a GSPR Compliance Checklist (with document review task)
- By the end of the project, the participant will be able to create a report on the manufacturer’s general safety and performance requirements and gather relevant information following the necessary criteria.
- Date: April 25, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 4: Creating a Validation Plan
- By the end of the project, the participant will be able to determine when validation is necessary and assess the quality of the validations received during the technical documentation review.
- Date: May 16, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 5: Evaluation of Manufacturer-Provided Documents (Instructions for Use and Labelling)
- By the end of the project, the participant will be able to critically evaluate the documents provided by the manufacturer.
- Date: June 13, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 6: Creating a Risk Assessment
- By the end of the project, the participant will be able to process and synthesize legal requirements and critically evaluate the risk management documentation.
- Date: September 19, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 7: Technical Documentation Evaluation I
- By the end of the project, the participant will be able to critically evaluate technical documentation.
- Date: October 17, 2025 (Friday)
- Instructor, mentor: Attila Juhász
Project 8: Technical Documentation Evaluation II
- By the end of the project, the participant will be able to critically evaluate technical documentation.
- Date: November 14, 2025 (Friday)
- Instructor, mentor: Attila Juhász
ON-SITE EXAM
Evaluation of Technical Documentation
Date: November 28, 2025 (Friday)
THEORETICAL PART (self-directed learning through an e-learning platform)
Specialized subjects for clinical experts
- Clinical Evaluation of MD Medical Devices (Subject Code: MR001, Author: Dr. Katalin Tauberné Jakab)
PRACTICAL PART (group projects under expert mentorship)
Online participation is available upon request.
Project 1: Summary of Clinical Evaluation Requirements
- By the end of the project, the participant will be able to identify and summarize the clinical evaluation requirements based on the MDR and other relevant regulations.
- Date: March 5, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 2: Planning a Clinical Evaluation According to the Law
- By the end of the project, the participant will be able to plan a clinical evaluation considering relevant legal requirements and guidelines, including determining the necessary resources and methods.
- Date: March 26, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 3: Collecting Documentation and Literature
- By the end of the project, the participant will be able to effectively gather and organize the necessary documentation and relevant literature for clinical evaluation, ensuring the reliability and legal compliance of the sources.
- Date: April 16, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 4: Evaluation and Screening of Literature with Justification
- By the end of the project, the participant will be able to critically evaluate and screen the collected literature, justifying the selection of relevant and reliable sources for clinical evaluation.
- Date: May 14, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 5: Reflection on the Statistical and Methodological Content of the Filtered Literature
- By the end of the project, the participant will be able to reflect on and critically analyze the statistical analyses and other methodological elements of the filtered literature, assessing the validity of the conclusions.
- Date: June 18, 2025 (Wednesday)
- Instructor, mentor: Dr. Katalin Tauberné Jakab
Project 6: Designing a Clinical Trial
- By the end of the project, the participant will be able to plan a clinical trial, including developing the study protocol, determining the experimental design, and identifying the necessary resources and methods for the trial’s execution.
- Date: September 24, 2025 (Wednesday)
- Instructor, mentor: Péter Hársfalvi
Project 7: Conducting a Clinical Evaluation
- By the end of the project, the participant will be able to conduct a clinical evaluation based on the predetermined plan and methodology, including data collection, analysis, and interpretation in compliance with legal requirements.
- Date: October 15, 2025 (Wednesday)
Project 8: Preparing a Clinical Evaluation Review Report Based on the Relevant MDCG Guide (CEAR)
- By the end of the project, the participant will be able to prepare a clinical evaluation review report based on the relevant MDCG (Medical Device Coordination Group) guidelines, ensuring the report’s completeness and legal compliance.
- Date: November 12, 2025 (Wednesday)
ON-SITE EXAM
Review of Clinical Evaluation
Date: November 26, 2025 (Wednesday)
The training is being implemented with the support of the Ministry of National Economy, within the framework of the Support Certificate with the identification number “ÁFF/2107/2021-ITM”.