QbD Conference

QbD conference 2023

October 9-11 | Brussels

Announcement: Conference Cancellation

We regret to inform you that the upcoming MDR & IVDR Conference has been cancelled.

Reason: Despite our best efforts and a strong lineup of speakers, we’ve observed lower than anticipated attendance. This trend aligns with the current market response to events of this nature, influenced by recent postponements announced by the EU Commission.

Refunds: All registered attendees will receive a full refund. The process will commence shortly, and we appreciate your patience as we work through each transaction.

Additional Arrangements: We understand the importance of the insights and knowledge we intended to share. As such, we are exploring options such as a virtual event or providing recordings with handouts.

We deeply appreciate your understanding and support during this time. For any inquiries or further details, please contact our Marketing Manager, Mr. Peter Goossens, at peter.goossens@qbdgroup.com.

Empowering Medical Devices & IVD Experts

The time to act on the MDR & IVDR transition is now!

We are set to explore the dynamic landscape of In Vitro Diagnostic Devices (IVDs) and Medical Devices (MDs) in Europe. This conference is a must-attend event for professionals seeking to stay ahead of the curve and navigate the ever-evolving European regulatory environment.

Building on the successful Qarad IVDR Conferences of the past 6 years, we now offer next to the IVDR track an additional MDR track, under the renewed format of the QbD Group Conference.

What to expect?

Join us as we bring together international leaders, including speakers from renowned notified bodies, manufacturers, and our very own Qarad and QbD Group experts. Together, we will delve into the latest trends, challenges, and opportunities surrounding IVDs and MDs, focusing on hot topics such as software and artificial intelligence.
During this conference, we will address the implementation of the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR) throughout the entire device lifecycle. From idea to patient, we will explore the implications and best practices for successful compliance in Europe.

The time to act is now!

To benefit from the extension of the MDR/IVDR transition period, manufacturers and their Notified Bodies need to have signed a written agreement for conformity assessment in a timely manner. Avoid delays due to unavailability at Notified Bodies.
Take the initiative and be proactive in planning your submissions. Don’t forget that the general safety and performance requirements have not changed and still are challenging and demanding hard work! Therefore, use this additional time to generate the necessary evidence that supports all your claims.

Including speakers from companies like …

3 days

October 9-11

Discover our three-day Conference offering separate IVDR and MDR tracks, both including an introduction day.

Our previous Qarad IVDR Conferences have been a huge international success thanks to participants from all over the world.

Discover the program of your preferred track below, as well as our beautiful new location Quartier Papier! 

Choose your industry track

Medical Devices Regulation track

Patient safety is of paramount importance in the field of medical devices. To uphold high standards, the European Union has implemented the MD Regulation 2017/745  (MDR), which prioritizes the safety and efficacy of medical devices across their entire lifecycle.

Under the MDR, medical devices undergo rigorous assessments and must meet stringent requirements to ensure their compliance with safety standards.

The MDR places a strong emphasis on the documentation and clinical evaluation of medical devices. Manufacturers are required to provide comprehensive documentation of the device’s design, development, and manufacturing processes. Additionally, they must provide robust clinical evidence to demonstrate the device’s safety and effectiveness.

At the QbD Group, we have the in-depth knowledge and expertise necessary to assist manufacturers, distributors, and importers of medical devices in ensuring compliance with legislative requirements throughout the entire lifecycle of a medical device.

In Vitro Diagnostics Regulation track

In today’s ever-evolving landscape of medical diagnostics, the field of in vitro diagnostics (IVD) is undergoing a rapid and transformative evolution. Propelled by groundbreaking technological advancements and a deeper understanding of medical science, the IVD industry is experiencing a remarkable journey of progress.

A pivotal milestone in this journey occurred in 2017 when the European Union unveiled the IVD Regulation 2017/746 (IVDR), a landmark legislation that set new benchmarks for regulatory requirements. This regulatory shift necessitates a high level of expertise and ample resources to navigate the complex landscape and ensure a swift time-to-market for IVD innovations.

At Qarad (part of the QbD Group), we understand the challenges inherent in this dynamic regulatory environment. Equipped with extensive experience and comprehensive knowledge, we stand ready to assist your company in overcoming all your regulatory hurdles.


Explore a wealth of new information and guidance documents to stay ahead of industry trends.*

Day 1

Monday Oct 9
IVDR track

to the IVDR

Hosted by our IVD experts

Our experts provide you with a good overview of the IVDR fundamentals. Suited for:

  • Regulatory professionals who are new to the IVDR.
  • More experienced regulatory professionals who want to refresh their knowledge on the IVDR.
MDR track

to the MDR

Hosted by our MD experts

Our experts provide you with a good overview of the MDR fundamentals. Suited for:

  • Regulatory professionals who are new to the MDR.
  • More experienced regulatory professionals who want to refresh their knowledge on the MDR.


Enjoy some drinks and bites while meeting fellow industry experts.
*Included in ticket

Day 2

Tuesday Oct 10


Hosted by our IVD experts
IVDR track
  • Challenges and opportunities experienced when complying to the IVDR, an industry perspective
  • Audit experience of the notified body, most common issues that they see (both with QMS and TD)
  • Bringing your IVD to the EU, Swiss or UK market, a roadmap
  • Software
    • Current legislative requirements for AI based medical devices
    • Verification and validation for AI/ML
    • Documentation requirements for software under IVDR


Hosted by our MD experts
  • Update on the latest guidelines and standards.
  • Discuss and tackle challenges with innovative devices and technologies.
  • Practical lessons on implementation of the MDR requirements, amongst others: design, clinical evaluation, labelling, registration and market access.
MDR track


Enjoy some drinks and bites while meeting fellow industry experts.
*Included in ticket

Day 3

Wednesday Oct 11


Hosted by our IVD experts
  • A notified bodies point of view on what structured dialogue is in reality
  • A practical approach on meeting clinical evidence requirements
  • The art of risk management and clinical benefit assessment
  • Setting up clinical performance studies and how the IVDR impacts clinical drug trials with the state of play for companion diagnostics
  • Addressing PMS and PMPF requirements
IVDR track

*Please be advised that the agenda is not entirely definitive and might be subject to slight modifications.

Meet our guest speakers

Stay tuned for exciting news! Our lineup of guest speakers will be revealed soon. Prepare to be inspired and enlightened as industry experts and thought leaders share their insights and expertise.

Koen Cobbaert

Koen Cobbaert - Sr. Manager Quality, Standards & Regulations (Philips)

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.

Read more
Marta Carnielli

Marta Carnielli - Head of Certification IVD (TÜV SÜD)

Marta Carnielli works for TÜV SÜD as Head of Certification IVD; in this role, she is responsible for the certification process for IVD medical devices as well ensuring accreditations, designation and authorization relevant to IVDs are maintained by TÜV SÜD.
She is representing TÜV SÜD in regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group.

Read more
Molly Rogers

Molly Rogers - Certification & Inspection Officer (NSAI)

Molly Rogers is currently working as a Certification & Inspection Officer with NSAI. Previous to NSAI, Molly worked as a Research and Development Scientist in multiple well-established and start-up IVD companies and has several years’ assay development experience from initial discovery, through design control, and to regulatory submission in multiple jurisdictions. Molly was a key member of NSAIs IVDR designation team and uses her vast scientific background & regulatory knowledge to assess conformity assessment activities under IVDR.

Read more
Alan Fraser

Alan Fraser - Consultant Cardiologist (University Hospital of Wales)

Alan Fraser is Consultant Cardiologist at the University Hospital of Wales, Cardiff, UK, and Emeritus Professor of Cardiology at the Wales Heart Research Institute, Cardiff University. He chairs the Regulatory Affairs Committee of the Biomedical Alliance in Europe and he is the Scientific Coordinator of the EU Horizon 2020 CORE-MD project (Coordinating Research and Evidence for high-risk Medical Devices).
He graduated in medicine from Edinburgh University and undertook his clinical training in Scotland, Wales, and the Netherlands.

Read more

Autumn Collasius - Head of Global Regulatory Affairs (QIAGEN)

Autumn Collasius serves as Vice President, Head of Global Regulatory Affairs for QIAGEN a Molecular Diagnostics and Life Sciences company. She joined QIAGEN in May 2021 having previously led Quality Assurance and Regulatory Affairs at OpGen, Inc., Curetis GmbH, and Nuo Therapeutics. Ms. Collasius’ is a seasoned regulatory and compliance executive within the medical device and diagnostic communities having developed regulatory strategies for diverse portfolios of molecular diagnostic products, including highly multiplex assays, bioinformatics tools, and NGS products for commercialization in the U.S., Canada, the E.U. under both IVDD and IVDR and globally.

Read more

MD Notified Body speaker

More information on this guest speaker will follow soon.

Read more

About the QbD Group

The QbD Group offers expertise for solving complex project problems in Quality Assurance, Validation & Qualification, Regulatory Affairs, Clinical, Lab Services, Software Services & Solutions and Business & Communications for companies active in the life sciences. Qarad is a brand part of the QbD Group.

Qualification & Validation

Quality Assurance

Regulatory Affairs

Clinical Solutions

Lab Services

Software Services

Business & Communications

Our Venue

Quartier Papier

We will host our first Qbd Group Conference at Quartier Papier, a beautiful location in the heart of Zaventem (Brussels, Belgium), less than 5 minutes away from Brussels-National Airport.


We are partnering up with Crowne Plaza, which is only a 5 minute walk from Quartier Papier. Book your room here to enjoy interesting conditions. 

  • Enjoy guaranteed best prices during the conference with a remarkable 20% discount compared to the best available rate under the same conditions.
  • Indulge in the convenience of having breakfast included with every overnight stay.
  • Experience the added convenience of a complimentary shuttle service, providing seamless transportation between Brussels Airport Zaventem and the hotel.
  • Embrace the advantage of being within walking distance to Quartier Papier.
  • Unwind in soundproof rooms, ensuring a peaceful stay without any disturbances from departing or arriving aircraft.
Yes, there is a free spacious car park in front of the building for approximately 95 cars (including 40 electric charging points).

Yes, it is. Quartier Papier is situated along the Brussels Ring, right next to the E40 and E19. Brussels-National Airport is located 1,2 km away from Quartier Papier, and it takes less than a 5 minutes to get there. For people coming by public transport, there is a bus stop at 150m (Zaventem Hoekplein) for bus lines 222,272 and 538. The train station of Zaventem is situated at 800m.


The ticket sale is on hold.

Register your ticket by filling in the information below. Be sure to book in time, because seats are limited!

Please note that attendees are kindly requested to choose only one path for the conference. It is either IVDR or MDR, as mixing the two paths is not permitted.


Buy your IVDR ticket including VAT.


Buy your MDR ticket including VAT.

Stay informed on conference updates

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Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.