Clinical Evaluation:
An Educational Conference by Edvance MedTech

This conference has been designed for the people actually doing the work. This is a knowledge sharing and learning event first, networking second.

The agenda has been drafted by Richard Holborow (BSI) and refined together with manufacturers and other notified bodies around what you need to know and what is useful in practice - not around what speakers want to present.

The conference covers the whole Life Cycle from a clinical perspective and the focus is on real case reports: where people ran into problems, what worked, what didn’t, and what you should keep in mind when doing the work yourself. 

The aim is simple: practical insight from people who have actually been through it.
9 – 10th
February 2027
Berlin,
Germany
Kaiserin-Augusta-Hospital
(KARL STORZ Visitor and Training Centre)

Join Industry Experts in

9 – 10th
February 2027
Berlin,
Germany
Kaiserin-Augusta-Hospital
(KARL STORZ Visitor and Training Centre)

Master the Medical Device Lifecycle: 

a Clinical Affairs Conference

Choose your track

Dedicated tracks for Lower-Risk and Higher-Risk & Implantable devices 

Real-World Case Studies

Apply concepts through real-world examples and regulatory scenarios included in each session.

Led by Renowned MedTech Experts

Conference Chairs and international faculty share practical insights and experience.

This event has been designed by


Richard Holborow

Global Head of Clinical Compliance at BSI Notified Body (NL) & BSI Approved Body (UK) 


Tom Melvin

Biomedical Alliance Europe, Edvance MedTech Scientific Board


Yu Jin

MDR Clinical & Regulatory Affairs Expert  | Freelance Clinical Reviewer & Clinician providing at Notified Body 


Nona Heueis

Clinical Affairs and Life Sciences Expert | Head of Clinical Affairs at Heraeus Medical 


Adam Kleinman

Associate Director, Medical & Scientific Writing at Philips | Medical Device Regulation Expert


Conference Agenda

The conference programme is organised into two parallel tracks, one for low or medium risk devices and one for high-risk and implantable devices. Participants pick the track most relevant for their work at registration.

Every topic is delivered as a structured 75-minute session beginning with an introduction, followed by a Notified Body perspective and three practical case presentations. This format combines regulatory insights with real-world examples, enabling participants to gain practical knowledge tailored to the challenges of their device class.
Each session will follow the structure:

Introduction
15 minutes
NB Perspective
15 minutes
3 Real-World Cases
15 minutes per case


Day 1 | Tuesday 9 February 2026

     10:00 - 10:15 | 15-minute Break

     11:30 - 12:00 | 30-minute Break

     13:15 - 14:15 | Lunch

     14:45 - 15:00 | 15-minute Break

     16:15 - 16:45 | 30-minute Break


Day 2 | Wednesday 10 February 2026

     09:45 - 10:15 | 30-minute Break

     10:45 - 11:00 | 15-minute Break

     12:15 - 13:15 | Lunch Break

     14:30 - 15:00 | 30-minute Break


Get involved

Case Studies

Which project have you worked on that others could learn from?
We already have plenty of ideas and examples for the agenda. But the more experiences we can bring together, the more useful the conference will be for everyone.
That’s why we’re looking for real case studies from people doing the work. Maybe a project didn’t go to plan. Maybe you had to make a difficult decision. Or perhaps you found an approach that worked particularly well. These are exactly the kinds of experiences others can learn from. 

What about NDAs?
We all work under NDAs, so of course no one expects you to share confidential information or company secrets. But you may be able to adapt the experience to a different device, anonymise the details, or frame the story in another way. The important thing is the lesson, not the confidential specifics. 

Keep it simple
Your presentation only needs to be 10 minutes, followed by 5 minutes of discussion. You don’t need to be an experienced speaker, and this isn’t about delivering a perfectly polished conference talk. It’s simply about sharing what you learned.

Introductions / NB perspective
We’re also looking for experienced speakers who can introduce one of the topics with a 15-minute presentation or share a notified body perspective on the topic, again in a 15-minute slot.

As a thank you
1 selected case study / speaking slots: 50% off your conference ticket
2 selected case studies / speaking slots: a free conference ticket
Please submit your case study by October 15. Our Chair Team will then select the cases we believe will work best for the programme.

Already bought your ticket?
No problem. Whether you booked early for the best price or simply didn’t want to miss out because places are limited, we’ll reimburse the difference if your case study is selected. You won’t pay more than you need to.
If you have a project you could share, please get involved. The more honest, real-world experiences we can bring together, the more valuable we can make the conference for everyone.

Meet the Conference Chairs

Tom Melvin
Biomedical Alliance Europe, Edvance MedTech Scientific Board


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.

Richard Holborow
Global Head of Clinical Compliance at BSI NotifiedBody (NL) & BSI Approved Body (UK) 

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU. 
Yu Jin
MDR Clinical & Regulatory Affairs Expert | Freelance Clinical Reviewer & Clinician providing at Notified Body

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.
Nona Heueis
Clinical Affairs and Life Sciences Expert | Head of Clinical Affairs at Heraeus Medical 

Nona Heueis is a microbiologist with a Phd focusing on RNA biology and antibiotic producing bacteria. Leaving academia behind and re-orienting towards industry came easy but scientific focus and love for evidence-based work stayed with her. She accompanied the (mindset) transition into MDR and navigates global strategy for medical devices in orthopedy and trauma with her growing team.
Adam Kleinman
Associate Director, Medical & Scientific Writing at Philips | Medical Device Regulation Expert 

Adam Kleinman is the Associate Director of Medical & Scientific Writing at Philips within the Hospital Patient Monitors business. Adam has been leading the team for 3 years and is responsible for clinical evaluations, post-market clinical follow-up, clinical investigation protocols and reports, and scientific publications. Adam has expertise handling clinical evaluations and notified body deficiency reports for devices ranging from class I to III under EU MDR during his time as a consultant at RQM+ and as a senior writer and team lead at Philips.

Pricing

Registration will open September 24th (September 22nd if you pre-registered)

We will have a limited number of Early Bird tickets available at 400 EUR plus VAT for self funded and 500 EUR plus VAT for corporate registration. The total number of Early Bird tickets depend on the sponsorship secured by September 21st.

For advanced access to the Early Bird tickets from September 22nd, please register below.

Self-funded*

Normal Price
500 €
plus VAT

The total course fee including VAT will be calculated for you during checkout. As this event is held in Germany, price including VAT will be 595,00 €

Corporate

Normal Price
750 €
plus VAT

The total course fee including VAT will be calculated for you during checkout. As this event is held in Germany, price including VAT will be 892,50 €


* 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.

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Frequently asked questions

We have just launched this website, there haven't been any frequently asked questions yet. 

Why do I have to select a track?

To create the best experience for all participants, the conference is organised into two dedicated tracks: Lower & Medium-Risk Devices and High-Risk & Implantable Devices. Due to limited room capacity, participants are asked to select one track when registering.

What if I want to attend sessions from both tracks?

We understand that some sessions in both tracks may be relevant to you. Where possible, sessions will be streamed in a separate room, allowing participants to follow key sessions from the other track as well. However, please note, that this may have limited capacity.

What certificates can I receive?

All participants will automatically receive a Certificate of Attendance after the conference. If you complete a short online knowledge test after the event, you can also receive a Certificate of Completion.

How do I submit a case study?

Please click on “Get involved” on our website or use the case study submission form.

Is there a specific format for case study submissions?

You do not need to prepare a presentation at the application stage. The submission form is designed to give us an understanding of your proposed case, the key insights or challenges, and the value it could bring to the audience.

Do I need to submit my presentation with my application?

No. A presentation is not required at this stage. If you feel that sharing a presentation would provide significantly more insight into your proposed contribution, you are welcome to submit it separately via clinical.conference@edvance-medtech.com. However, polished slides are not a requirement — the content and value of the case are much more important to us than the presentation format.

What is the format of each case presentation?

Each presentation will be 15 minutes in total, consisting of:
  • 10 minutes for the presentation
  • 5 minutes for questions and discussion

The presentation will be positioned within the context of a Notified Body perspective and an introduction to the overarching topic. Each session will feature three presentations, with the aim of providing complementary insights into the topic.

What makes a good case study?

We are particularly interested in cases that provide genuine learning and practical insights. A challenge, setback or unexpected outcome can be just as-or even more-valuable than a process that went smoothly. We encourage you to consider:
  • What can the audience learn from your experience?
  • Does the case provide an insight that others can apply to their own work?
  • Does it address a challenge that occurs regularly in practice?
  • Does it reveal a particular pattern, lesson or approach that others may not have considered?
  • Does it complement the other contributions in the session?

Does the case need to be a common or frequently occurring issue?

Not necessarily. Recurring challenges can be particularly valuable because of their practical relevance, but a rare or “corner case” can also be highly valuable if it provides meaningful insight into a specific issue, pattern or lesson.

Do I need to be an experienced presenter?

No. We are not looking primarily for polished presentations or extensive speaking experience. While these can be helpful, our focus is on the quality and relevance of the content. Our aim is to identify real-world insights that participants can take away and apply in their day-to-day work, rather than simply great presentations that leave the audience inspired but without a tangible learning outcome.

How will case studies be selected?

Submissions will be reviewed against several criteria, with particular attention to:
  • Learning value: What can the audience take away from the case?
  • Relevance and applicability: Can the insight be applied to participants’ day-to-day work?
  • Complementarity: Does the case add a new perspective to the other contributions in the session?
  • Quality of insight: Does the case reveal a meaningful challenge, lesson, pattern or solution?


Ask your question:

Ask us anything you'd like to know about the conference. 
If you add name and email, we will reach out to you directly with the answer as well as include it in the FAQ. If you prefer to submit your question anonymously, please check back here in a week or two.