Lesson series

What the **** is Regulatory Affairs? 

A deep dive for people who want to know more about regulatory affairs and those who have to.

Regulatory affairs is a key driver in ensuring the safety and performance of medical devices and serves as the gateway to the market.
Although it is often viewed and treated as a stand-alone function, it is in fact a fundamental part of the job for everyone involved in the development, design, marketing, and sales of a medical device.
Consider marketing managers who must navigate strict legal frameworks; product managers whose specifications directly affect product compliance and registration; engineers whose solutions must be built accordingly; as well as professionals in startups, regulatory teams, and even healthcare providers who ultimately receive these products and messages.
Yet many of those involved have little to no formal training, and when they do, it is often limited to their own areas. This can create tension between internal departments, manufacturers, and healthcare professionals, resulting in frustration and inefficiencies.
What the **** is Regulatory Affairs? is a comprehensive course that brings together these lived experiences and perspectives, creating a shared foundation for everyone involved to discuss, understand, and influence decisions based on regulatory requirements.

Format

Online
Course

Starting date

May 11, 2026

Available for

6 months

Duration

14 sessions


Weekly sessions every Monday and Wednesday at 12:00 PM CET
No session on 25-05-2026 due to public holiday.*

Recordings will be available for up to 6 months.

What can you expect?

Across 14 interactive 90-minute sessions, participants gain a structured and practical introduction to Regulatory Affairs for medical devices. Each webinar includes a 45–60 minute presentation, followed by live Q&A to foster exchange and clarity

The program is designed for those planning a career in regulatory affairs as well as professionals in startups or MedTech companies who are newly responsible for regulatory activities.

Meet the Speakers

Michael D'Agosto

MODERATOR
Michael D’Agosto is Professor and Dean of Studies M.Sc. Medical Devices - Regulatory Affairs at Hochschule Furtwangen University. He is a medical doctor (MD) and medical engineer by training and worked in the medical device industry prior to his academic career. Michael is also Scientific Expert and Partner at Escentia GmbH.  Michael has been part of Edvance MedTech from the very beginning, sharing his expertise and experience. He is essential for our progression with his ability to explain complex issues in a comprehensible way and for his openness to support everyone. 

Cécile van der Heijden

MODERATOR
Cécile van der Heijden is an attorney-at-law at Axon Lawyers and strategist in European life sciences regulation, with expertise spanning MedTech, AI, data, biotech and health law. Her special interest lies with cross-legislation and FemTech. Recognised for her cross-legislation expertise, she brings coherence to complex regulatory frameworks. She is a frequent speaker at international conferences and has published on medical devices, data governance, and health law, as well as on history, combining professional practice with academic inquiry. 

Elisabeth Oltmanns

MODERATOR
Elisabeth Oltmanns is a PhD student and her research focuses on the integration of clinical and non-clinical data (eclipse-md.com). With a background in Biomedical Engineering and an MSc in Regulatory Affairs, she combines technical expertise with regulatory insight. Alongside her academic work, she consults through Escentia, a boutique clinical affairs consultancy supporting medium-risk medical devices. Passionate about advancing medical device development, she is dedicated to transforming clinical evaluations from a regulatory requirement into a strategic advantage. 

Laura Irwin Rossing 

Regulatory Affairs specialist
Laura Irwin Rossing is a Regulatory Affairs specialist focused on EU medical device compliance, with hands-on experience supporting small and emerging enterprises. She works closely with startups and SMEs to navigate the EU MDR, helping them build practical, scalable regulatory strategies. Her approach emphasizes in providing a pragmatic level of documentation, efficient processes, and realistic pathways to CE marking.

Nina Dusper

Director of Quality & Regulatory Affairs 
Nina Dusper is a senior Quality and Regulatory Affairs leader with more than a decade of experience in global medical device compliance, regulatory strategy and international submissions, and quality system transformation. As Director of Quality & Regulatory Affairs at RetInSight GmbH, she defines and leads the company’s quality and regulatory framework for pioneering AI-supported medical devices in ophthalmology. Her expertise spans FDA regulations, EU MDR, global market registrations, UDI implementation, and audit readiness.

And more...

Why you should join this course

Regulatory requirements for medical devices have become significantly more complex under the EU MDR and related global frameworks. This course provides a comprehensive and practical foundation in Regulatory Affairs, from classification and conformity assessment to quality systems, risk management, post-market obligations, and software/AI considerations. It is designed to build strategic understanding, not just procedural knowledge.




You will learn to
  • Interpret and apply key EU MDR requirements across the device lifecycle
  • Understand classification rules and conformity assessment pathways
  • Structure technical documentation in line with Annex II and III
  • Integrate ISO 13485, risk management, and design controls into regulatory strategy
  • Navigate post-market surveillance, vigilance, and emerging topics such as SaMD and AI
  • And so much more…

Self-funded*

Early Bird
250€
Normal Price: 500€

The total course fee including VAT for your country of residence for self-funded or student / young professional will be calculated for you on checkout.

Corporate

Early Bird
500€
Normal Price: 750€

Special team pricing is available if you would like to make this course available to more members of your team. Please contact us on registration@edvance-medtech.com for more information.
The total course fee including VAT will be calculated on checkout.


Please note: The early bird rate will be available until May 5th, 2025 and applies only if payment is received by that date. If payment is not received within that period, the standard course fee will automatically apply, and a corrected invoice will be issued if necessary.

* Self-funded professional discounts apply exclusively to registrations and payments made by natural persons as B2C Customers. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the self-funded professional discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.

Self-funded*

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Please refer to the table at the end of the page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.

Corporate

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Special team pricing is available if you would like to make this course available to more members of your team. Please contact us on registration@edvance-medtech.com for more information.

Student**

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Verified by using Student Email or providing link to personal LinkedIn (minimum 30 connections). If no verification is provided, our registration team will contact you for alternative verification methods.
Please refer to the table at the end of the page for the total course fee including VAT for your country of residence for self-funded or student / young professional registrations.


Please note: The early bird rate ended January 10th, 2025 and applies only if payment is received by that date. If payment was not received within that period, the standard course fee will automatically apply, and a corrected invoice will be issued if necessary.

* Self-funded professional discounts apply exclusively to registrations and payments made by natural persons as B2C Customers. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the self-funded professional discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.

**Student discounts apply exclusively to registrations and payments made by natural persons as B2C Customers who provide valid proof of current enrollment in an accredited educational institution or graduation from an accredited educational institution within the past three years. If a Customer provides a VAT number or business information beyond a business email address during registration, Edvance MedTech will classify the registration as a B2B Customer registration, making the student discount inapplicable. In such cases, Edvance MedTech will invoice the Customer for the price difference and applicable VAT. Access to the relevant Educational Services will be withheld until full payment of this invoice is received.