Laboratory at the Faculty of Materials Science and Technology, VSB-TUO
ONLINE COURSE · CERTIFICATE FROM FMT VSB-TUO

Regulatory Affairs 
certificate

Bringing a medical device to the European market requires more than innovation. It requires regulatory strategy. Practical training for medical device professionals, engineers and companies preparing products for the EU market under MDR.

SHORT
STUDY LENGTH
PRACTICAL
FOCUS
CERTIFICATE
FROM FMT VSB-TUO
KNOW-HOW
THE MARKET NEEDS
Why this course

One specific skill.
Demonstrable results.

Companies are looking for people who can solve today's problem — not those who studied its theory ten years ago. A faculty certificate is the fastest way to move your career forward. That is why we run this one course — Regulatory Affairs for practice — and nothing else on this page.

A recognised university certificate

Proof of professional competence  from an accredited public university. It doesn't replace a degree — it complements it where that matters in practice.

Built for working professionals

The workload is designed to fit alongside a full-time job. You don't need to take leave, and you return to work with something you can use straight away.

Lecturers from the field

The course is taught by people who do this work every day. No slide decks about "how it should be done".

Up-to-date legislation

Regulation often changes faster than companies can keep up with. We respond to the changes and amendments every organisation needs to handle in day-to-day operations. The aim is not to overwhelm your staff, but to help optimise the whole process.

The only course we offer here

Regulatory Affairs
for practice

Gain an edge in medical device regulation. This is the single programme available on this page, and it ends with a certificate issued by FMT VSB-TUO.

MedTech / Regulation
Faculty certificate

Regulatory Affairs in Practice

From regulatory requirements to market-ready medical devices.

Medical device regulation is not just about knowing the MDR, the IVDR or individual standards. In practice you need to know what has to be prepared, why a given document is required, what evidence it rests on and how it connects to the rest of the technical documentation and the quality management system.

What you take away
  • 65 hours of direct teaching (every second Friday)
  • Access to specialised study materials
  • Practical checklists and template document structures
  • University certificate from FMT VSB-TUO
  • Case exercises and examples of real regulatory decisions
Who it is for

For companies entering the EU market, product and engineering teams, and Regulatory Affairs and Quality professionals, this course provides a practical understanding of the complete medical device lifecycle — from MDR requirements and EU market access strategy to connecting design decisions, risk management, technical documentation and regulatory processes.

Length
10 blocks
Workload
65 + 65 h
Completion
Certificate
Language
EN
Next run
16 October 2026
Course price
4 000 €
incl. VAT
Course detail
How it works

From application to certificate
in one semester

  1. 01

    Get to know the course

    Read through the Regulatory Affairs programme and its outcomes — or get in touch and we will gladly answer your questions.

  2. 02

    Apply online

    A short form, your company's billing details and a reserved place in the next run.

  3. 03

    Complete the programme

    Entirely online — live teaching, practical exercises and independent preparation.

  4. 04

    Receive your certificate

    Once you meet the learning outcomes you receive an official FMT VSB-TUO certificate listing your competences.

Frequently asked questions

Everything you need to know

What certificate do I receive?+
You receive an official certificate issued by the Faculty of Materials Science and Technology, VSB – Technical University of Ostrava. It documents a specific set of knowledge, skills and competences you have gained — not just attendance, but a demonstrable learning outcome.
What is the certificate worth on the job market?+
It is issued by an accredited public university and names the specific competences you can demonstrate. You can share it with employers and educational institutions at home and abroad — for example on LinkedIn or in your CV.
Does the certificate replace a university degree?+
No. The certificate does not replace a degree — it complements it wherever you need to demonstrate a specific, up-to-date competence that traditional study did not cover, or that new legislation has introduced. It is the fastest way to prove you can do something the market needs right now.
Do I need a university degree to enrol?+
Completed secondary education is enough for this programme. The exact entry requirements are listed on the course detail page.
What does the teaching look like and how much time does it take?+
This course is designed so that a working professional can manage it — the whole programme runs entirely online, with live teaching every second Friday, practical exercises and independent preparation. The full format and workload are stated on the course detail page.
How do I actually obtain the certificate?+
The certificate requires active participation in the teaching and verification of knowledge — typically a final project, or a written or oral examination. The exact conditions are set by the programme guarantor and listed in the course detail.
Can my employer pay for the course?+
Yes, most participants take this route. We issue a proforma invoice as well as a final tax document made out to your company. 

This course can also be used for corporate staff development. If you are interested in a dedicated run for your team, get in touch and we will prepare an offer.
Do I have to buy the whole course?+
No. You can take only the modules you need — each module costs 750 € incl. VAT. After completing your chosen modules you receive a Certificate of Completion. The full faculty certificate is available only when you purchase the whole course.
When does the next run start?+
The current dates are listed on the course detail page. If you would like to reserve a place in advance or arrange a dedicated run for your company, write to us — we will reply promptly.
Under what conditions does the course open?+
The course opens only with a minimum of 5 participants. If this number is not reached, the start may be postponed or cancelled, in which case any fees paid will be fully refunded.
Ready to expand your practice?

The next semester
can change your career.

Write us a few lines about what you do at your company and we will tell you how this Regulatory Affairs course can help you most.