Program day 3 | 13 October

9:00-17:00 Clinical Evidence and Clinical Studies to Support the IVDR

Clinical evidence is the cornerstone of the IVDR and an area of a significant uplift in expectations. This session will look at what clinical evidence is needed to support IVDR and how to generate studies to meet the expectations pre- and post-market. 

The following topics will be discussed during this workshop: 

• Intended purpose 
• Performance evaluation plan 
• Analytical and Clinical performance 
• Study objectives and intended population and user 
• Clinical study performance plans 
• Clinical study applications and ethics committee applications under the IVDR 
• Running and monitoring a clinical performance study 
• Preparing the Clinical Performance Report for new and legacy devices and CDx. 

Trainer(s):

• Sue Spencer (Qserve Group)
• Jude O'Donnell (Qserve Group)
• Kristiane Schmidt (Qserve Group)

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9:00-17:00 FDA pre-submissions

It takes time and money to compile regulatory dossiers for the registration of devices. Prior to completing verification, validation, and clinical investigations, it is vital to be aware of FDA expectations and acquire input regarding clinical evidence given the regulatory environment's ongoing changes. As part of its pre-submission program, the U.S. Food and Drug Administration (FDA) provides multiple avenues via which a manufacturer can directly ask the FDA for comments on proposed research designs and techniques for medical devices.

This workshop will address the various types of pre-submissions, or Q-submissions, that manufacturers have access to and how to leverage these to reduce the time and costs to bring medical devices to market in the United States.

The following learning objectives apply to this workshop:

• Identify the pre-submission options offered by the FDA for obtaining direct feedback on proposed devices and recognize when the different types of pre-submissions can be used
• Construct meaningful questions to obtain the necessary feedback to move forward with the next steps in the regulatory pathway
• Describe the content necessary to complete the different types of pre-submissions
• Appy learning to example devices and scenarios.

Trainer:

• Lorry Weaver (Qserve Group)

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9:00-17:00 Challenges of Risk Management Under MDR

The challenges discussed will include disclosure of residual risk, defining “As Far As Possible”, developing a compliant policy for risk acceptability, justifying criteria for risk acceptability, how to define indicators and threshold values for benefit-risk, justifying the specific and measurable clinical outcomes, and disclosing quantitative risks in SSCPs/SSPs for a variety of medical devices and IVDs.

Trainer: 

•  Keith Morel (Qserve Group)
• Coenraad Davidsdochter (Qserve Group)
• Thomas Ostermeier (Qserve Group)

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9:00-17:00 MDR 6 years later - Lessons Learned

Although the transition is still ongoing the MDR has already been published for about six years, during which we have gained significant experience in understanding how requirements are expected to be practically applied, how member states interpret the legislation, and how to effectively handle Notified Bodies expectations. These sessions will address the main topics of the MDR presenting the most common pitfalls and how to practically prevent or overcome them. We will focus on how to effectively use the extended transitional period and how to keep MDD files up to date while already keeping the MDR requirements in sight.

The following topics will be discussed during this workshop:

• General Introduction
• High-level Risk Management
• Clinical Lessons learned
• QMS Lessons learned
• Technical Documentation Lessons learned
• Biocompatibility Lessons learned
• Q&A

Trainer(s):

•  Giovanni Di Rienzo (Qserve Group)
•  Robert Paassen (Qserve Group)
•  René Schings (Qserve Group)
•  Bianca Lutters (Qserve Group)
•  Stéphane Naudin (Qserve Group)

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9:00-17:00 ISO 14155 and PMCF surveys

9:00-12:30 ISO 14155

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials that involve the participation of human subjects. The ISO 14155:2020 standard addresses GCP for medical device studies. Studies in Europe must comply with the standard, and the standard is also recognized by the US FDA and many other regulatory authorities around the globe. This training provides an introduction to the ISO 14155 standard and GCP principles for medical device studies.

Trainer:

•  Armêl Plaine (Qserve Group)

13:45-17:00 PMCF Surveys

PMCF user surveys are questionnaires to end-users of a medical device that are designed to collect clinical data. To be able to use those data to support that you have sufficient clinical data under the Medical Device Regulation (MDR), a high-quality survey is required. Such a survey is patient-specific and well-designed, with clearly stated endpoints, a statistical analysis plan, and an appropriate rationale for the design, among other requirements. In this training, we will examine in detail how a survey can be designed, conducted, and reported, including the definition of endpoints and statistical considerations. The use of PMCF user survey data for other geographies than Europe will also be discussed.

Trainer:

•  Bianca Lutters (Qserve Group)

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