The transition to the EU In Vitro Diagnostic Regulation (IVDR) is one of the most significant shifts facing manufacturers and suppliers of IVD products. With stricter requirements, evolving timelines, and increasing documentation demands, organizations often struggle with:

• Understanding and interpreting IVDR requirements
• Preparing robust technical documentation under tight timelines
• Managing complex certification processes with notified bodies
• Ensuring long-term compliance while keeping pace with market demands
• Leveraging digital tools to simplify and strengthen compliance

This webcast addresses these challenges directly, drawing on DNV’s experience as a notified body and highlighting practical strategies to support long-term success.

What you will gain from this session:

• A clear update on the state of IVDR and upcoming timelines.
• Insight into the biggest compliance challenges facing IVD companies today, based on our LinkedIn community poll
• A step-by-step overview of the certification process, from quote request to contract and certification
• Practical examples of how digital tools and data can streamline IVDR readiness, documentation, and reporting
• Tailored advice from industry experts, with the chance to ask questions directly

Registration Fees & Deadlines

Learning Objectives

• Identify the major design control elements and understand their contribution to the development of safe and effective medical devices.
• Understand how human factors fit into product development and design controls.
• Outline and describe the costs associated with human factors studies.
• Develop strategies for identifying device users, user environments and critical tasks.
• Identify methodological differences between generative, formative, and validation/summative studies.
• Be able to make decisions based on results from human factors studies and document them in the usability engineering file.

Who Should Attend?

Members of firms manufacturing components or entire IVD medical devices. Particular focus on compliance/quality. Session especially valuable for manufacturers wanting to maximize access to the EU market.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Keneth Fuh, PhD, DNV
IVDR Technical Manager

Kenneth Fuh is a biomedical engineer and diagnostics expert serving as technical lead for IVDs at DNV, where he advances global conformity assessment and regulatory excellence in medical technologies. He earned his doctorate in biomedical engineering from the University of Calgary. Earlier in his career, he co-founded Syantra Inc. and helped develop Syantra DX, a blood-based gene-expression test for early breast-cancer detection. With a background in biomarker research and diagnostic development, Fuh now focuses on ensuring the quality, safety, and performance of innovative IVD solutions worldwide at DNV.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions