1. 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.
2. 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 (IVDR 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 (IVDR 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 (IVDR Annex VII and NBOG’s BPG 2017-2, Section 5.4)
Required qualification:	Required Professional Experience:
The IVDR does not specify exact qualifications. However, the related Guide (NBOG 2017-2) generally expects a medical qualification.	The IVDR 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: At least two years of professional experience in the evaluation of clinical data for medical devices (experience in a similar field, such as the pharmaceutical industry, may also be considered). Direct work experience in patient care. Direct work experience in clinical research or related experience, especially in conducting preclinical or clinical trials, or in evaluating clinical data.

Duration: 10 months

The training is currently under preparation, but we are already accepting pre-registrations. 

If you would like to secure your spot, click the ”Pre-registration” button at the bottom of the page.

Dates: 

• Core Module + Site Auditor Supplementary Module: Soon!
• Core Module + Product Reviewer Supplementary Module: Soon!
• Core Module + Clinical Expert Supplementary Module: Soon!

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 IVDR 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 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:

1. 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! 

2. 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.