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Regulatory Affairs Basic course (EU)

Regulatory Affairs is one of the most in-demand skills in MedTech — and one of the hardest to break into without hands-on experience. RA Basics Starter gives you a practical first foundation: the core logic behind MDR classification, GSPRs, verification & validation, and clinical development strategy, applied to a real case rather than left as abstract theory.

In a single live seminar day, you’ll learn how regulatory decisions actually get made. Over the following three weeks, you’ll practice that logic on a guided case study, then apply it yourself to build a real, reviewed work sample — something you can point to, not just a certificate that says you showed up.

By the end, you’ll have a working understanding of how medical devices move through the EU regulatory system, and a concrete example of your own thinking to show for it.

On the 6th of October from 9 am to 3.30 pm

The Problem

Regulatory Affairs training usually gives you theory and a generic case study. You leave with a certificate that says you attended — but no real, product-specific output, and no confidence that you could actually build a classification, GSPR list, or clinical strategy on your own.

If you’re working with (or want to work with) medical device companies, that gap shows up fast — in job interviews, in your first project, or the first time your manager asks “can you draft this?”

What Makes This Different

Most 1-day Regulatory Affairs seminars end when the day ends. This one doesn’t.

  • Day 1 (6 hours, live): The core theory — classification logic, GSPRs, verification & validation, and clinical development strategy under the EU MDR.
  • Weeks 1–3 (self-paced): A guided case study to practice the method, then application to your own product idea using structured templates.
  • End of Week 3: You submit a complete regulatory & development strategy — for your own product.
  • Certification: Your submission is reviewed against a fixed evaluation rubric. Pass, and you receive your RA Basics Starter (EU) Certificate of Completion.

What You’ll Be Able to Do

By the end of the program, you will be able to:

    • Determine the correct MDR risk classification for a medical device and justify it with the right Annex VIII rule
    • Identify the applicable General Safety and Performance Requirements (GSPRs) and map them to harmonized standards
    • Outline a verification and validation concept, including concrete acceptance criteria
    • Decide whether a clinical investigation is required — or whether a literature-based clinical evaluation is sufficient — and justify that decision

Who This Is For

  • Professionals moving into Regulatory Affairs, Quality, or Clinical Affairs roles in MedTech
  • Founders and product developers who need to understand the regulatory logic before talking to a Notified Body or consultant
  • Anyone who wants a practical, certified entry point into EU MDR regulatory strategy — without committing to a multi-month program

Note: This course is delivered in English and does not require prior regulatory experience.

How it works

Step

What Happens

1. Enroll

Secure your seat in the next live cohort (max. 15 participants)

2. Live Seminar (Day 1)

6 hours of theory — classification, GSPR, V&V, clinical strategy

3. Case Study

Practice the method on a provided example product

4. Your Own Strategy

Apply it to your own product idea using the guided template

5. Submit & Get Reviewed

Submit within 3 weeks; receive written feedback within 5 business days

6. Certificate

Pass the evaluation and receive your certificate

The course starts on October 6th and costs €349 — discounts available for job seekers, PhD candidates, and students.

 

Feel free to reach out with any questions or interest

Contact us now

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