Lesson series

PMCF Blueprint: Building evidence that matters

PMCF is one of the most powerful, yet most underused, tools in the clinical and commercial strategies of many medical device companies.

Too often, it is seen merely as something to get done to reach the market, and a burden once there. What begins as a chance to strengthen strategy and evidence is reduced to a formality.
Yet, when used properly, PMCF becomes the key mechanism to build, sustain, and expand the clinical evidence base over the lifetime of your device. It allows you to stay ahead of potential risks, substantiate new claims, and explore additional indications. It also helps you meet your Notified Body’s expectations and produce the real-world evidence that decision makers, HTA bodies, and payers increasingly demand before they consider reimbursement.

This course will help you turn PMCF into a clear and structured part of your clinical, regulatory, and commercial planning. Whether you see PMCF as a challenge or already view it as a strategic asset, you will learn how to link clinical, commercial, and market access goals through a meaningful and systematic PMCF approach that adds measurable value to your company’s long-term success.
Format

Online
Course

Starting date

September 22, 2026

Available for

6 months

Duration

10 sessions

Level

Intermediate


Weekly sessions every Tuesday at 13:00 - 14:30 PM CET

Recordings will be available for up to 6 months.

Why you should join this course

PMCF is often treated as a regulatory obligation, but when used strategically, it becomes a powerful driver of clinical evidence, market access, and long-term product success. This course shows you how to turn PMCF into a structured, value-adding part of your overall strategy.

You will learn to

  • Turn PMCF into a strategic tool, not just a requirement
  • Build and sustain clinical evidence across the product lifecycle
  • Link PMCF with clinical, regulatory, and commercial goals
  • Support claims, manage risks, and explore new indications
  • Gain insight into Notified Body expectations and reimbursement demands

What can you expect?

Across 10 focused sessions, you will gain practical guidance, real-world perspectives, and actionable tools to plan and implement PMCF activities that meet regulatory expectations while creating clinical and commercial value.

Meet the Speakers

Michael D'Agosto

University teacher | Edvance scientific board member

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

Attorney-at-law | Senior Legal Counsel at Axon Lawyers

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

Managing partner at escentia

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. 

Amie Smirthwaite

founder of salvae medical

Amie Smirthwaite is a clinical and regulatory affairs expert with over 30 years’ experience in medical devices, spanning product development, regulatory systems, and clinical evidence. She contributes to ISO committees, including TC195/WG4, and drafted ISO 18969.
Currently an independent consultant, she previously served as Global Head of Clinical Compliance at BSI, where she built and led clinical evaluation processes. She is also Chair of the Education Committee for ICEPS and a Fellow of the Regulatory Affairs Professionals Society.

Yu Jin

MDR Clinical EXPERT 

Yu Jin is a clinical and regulatory affairs specialist with an MD and PhD in cardiology and cardiovascular epidemiology. With over 15 years of experience across clinical practice, research, the medical device industry, and regulatory sectors, Dr. Jin has developed a comprehensive understanding of both the clinical and scientific aspects of medical device development and evaluation.
Currently a consultant, her career has included leadership roles in clinical and regulatory strategy, particularly in the areas of EU MDR clinical evaluations and clinical investigations. Dr. Jin has extensive expertise in the Notified Body conformity assessment process, including Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, and clinical investigations.An author of over 50 peer-reviewed scientific publications, Dr. Jin is also recognized for her deep clinical expertise in cardiovascular devices.

Marcus Torr

HEAD OF POST-MARKET SURVEYS AT PURDIE PASCOE

Marcus is a Post Market Survey expert with over seven years of experience in real-world evidence generation for the medical device and IVD industries. He joined Purdie Pascoe in 2015 after completing a First Class MSci in Natural Sciences (Chemistry with Pharmacology) at the University of Bath.
After nearly five years in primary market research, Markus transitioned into leading the Post Market Survey team in 2019. In this role, he has grown the team to 15+ specialists and overseen the delivery of more than 500 surveys across PMCF (EU-MDR), PMPF (EU-IVDR), and broader real-world data programs. His work spans a wide range of device types, including both general (Level 8) and case-specific (Level 4) surveys, many of which have been approved by leading Notified Bodies.

Tom Melvin

UNIVERSITY TEACHER | EDVANCE SCIENTIFIC BOARD MEMBER

Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the Biomedical Alliance Regulatory Affairs Committee and a member of the European Medicines Agency Expert Panels for medical devices, the European Society of Cardiology Regulatory Affairs Committee and the National Research Ethics Committee for Medical Devices.   Tom previously worked at Trinity College Dublin and was a senior medical officer for medical devices at the Health Products Regulatory Authority and Co-Chair of the  MDCG CIE working group.  Tom has been part of Edvance MedTech from the very beginning, contributing invaluable knowledge and insight, while also keeping the founding team grounded and focused when our ideas risked running too wild.

And more...

Self-funded*

250€
Normal Price: 300€

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

500€
Normal Price: 750€

Special team pricing is available if you would like to offer this course 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.

Student**

200€
Normal Price: 250€

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 will be available until April 28th, 2026 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.

Student / Young Professional / Self-funded pricing by country

Feel free to contact out team on registration@edvance-medtech.com if your country in not included and you wish to know the price including VAT before registration.

Our students say 

Excellent speakers, interesting discussions, fun and great atmosphere.
andrea
Your initiative is inspiring, with a great delivery and perfect timing. The team is welcoming and shows a very serious intent to find and propose ways of sailing through the realities imposed by
the MDR and its implementation...
Bruno Oliviera, cmo
It is a very interesting and informative course, excellent trainers/speakers.
peter

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