5th Qserve MedTech Conference 2023
Program of day 2
After the word of welcome, we start the day by presenting the hot issues outside Europe, a follow-up of the subject on day 1. On day 2, again, you can join one of four parallel sessions with in-depth information and experiences from the field. After your registration, you will soon receive an email from the Marketing team in which you can customize your program and select your preferences for the sessions to attend.
The round table discussion finishes with a Q&A with the audience, and Gert Bos will close the day on stage with a final panel discussion with some of our internal and external speakers.
Program of 12 October 2023
9:00 - 9:15 Opening
You will be welcomed to the 5th Qserve MedTech Conference by the Board of Qserve, Jan van Lochem, Gert Bos, and Martin de Bruin.
9:15 - 10:00 Hot Issues Outside of Europe
In this opening panel, Gert Bos (Qserve Group) will be exploring the latest developments and hot issues arising in the context of global regulatory compliance in a moderated debate.
Gert will be joined by Erik Vollebregt (Axon Lawyers), and Sophie Tabutin (W.L. Gore).
10:30 - 11:45 Quantitative Benefit-Risk Assessment
This session will cover aspects of quantitative benefit-risk assessment. Fundamentals of benefit-risk assessment will be covered. Topics covered will include methods for Defining Indicators & Threshold Values for Benefit-Risk Analysis, justifying risk acceptability criteria, presentation of quantitative risk in SSCPs, and ways to define specific and measurable clinical outcomes.
Speaker profiles:
10:30 - 11:45 IVD Go-To-Market Strategies to Focus on FDA
Traditionally IVD manufacturers entered the EU market before looking at the US and ROW. Extended review timelines are pushing manufacturers to think differently and look at the US first. This session will cover go-to-market strategies and secrets to a successful submission.
Speaker profiles:
10:30 - 11:45 Post-Market Clinical Follow-Up: How to Create and Maintain an Efficient Long-Term Strategy
This workshop will focus on how manufacturers can effectively collect long-term proactive PMCF data. PMCF surveys, but also other options to collect data will be discussed.
Speaker profiles:
10:30 - 11:45 Market Access Beyond the EU and US Market
This session will focus on entering the global market with the use of EU/US approval. Several countries in Asia, South/Latin America, and MEA recognize EU/US approval for in-country registrations. Manufacturers will learn how to adjust their technical documentation in such a way that it can be used for submission to the competent authority. We will also address the substantial differences that need to be considered when additional clinical testing is required.
Speaker profile:
13:45 - 14:45 SSCP: understanding it and making it understandable
The Summary of Safety and Clinical Performance (SSCP) is an EU-MDR required document which has two parts: one intended to the healthcare professionals, and another intended to lay users. It is the last technical document to be elaborated in the development of a new device and, as such, it is particularly impacted by previous project decisions. As a recent requirement, it has been the target of many questions from the Notify Bodies (NBs). This session will present how decision making in clinical data collection, risk management, post-market surveillance and clinical evaluation can impact the SCCP, showing examples of common questions asked during the EU-MDR submission process. Special focus will be given to tips and tricks on how to write best for lay users, as this is one of the main struggles of the manufacturers.
Speaker profile:
13:45 - 14:45 Annex XVI devices: are MDR requirements different from devices with a medical purpose?
This session focuses on the requirements in the MDR and the common specifications for devices without an intended medical purpose (Annex XVI of the MDR) and how those are different (or not) from the MDR requirements for devices with an intended medical purpose. During the session differences will be clarified and options on how those differences can be addressed will be discussed.
Speaker profiles:
13:45 - 14:45 Biological Safety Evaluation for Legacy Devices
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The biological and safety evaluation of legacy devices must be updated when manufacturers recertify their medical devices according to MDR. This workshop aims to offer concrete strategies on how to review, and improve your documentation and make it compliant with the current requirements.
Learn about:
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A list of required updates (e.g. significant changes to the ISO 10993 standards, ERC/GSPR, standard gap assessments, risk analysis, PMS data).
- Biological and physicochemical test strategies
- Practical examples looking at "dos and don'ts"
Speaker profiles:
13:45 - 14:45 REACH and RoHS - Attaining documented substance compliance according to MDR (and other global regulations)
In article 10.4 of the General Safety and Performance Requirements of the MDR, requirements are defined for risks posed by substances in the design and manufacturing of medical devices. But these are not the only regulations that apply. A manufacturer also needs to consider compliance with REACH, RoHS, etc. To determine compliance with these regulations a manufacturer must implement a process to gather the required information and build documented evidence by working with its suppliers, perform testing and/or perform risk assessments, determine the need for labeling, justification, and registration, or even consider a redesign of the (current or future) medical devices. This session shares some of the “good, bad, and ugly” of such projects.
Speaker profile:
13:45 - 14:45 Regulatory Insights Workshop: Empowering Start-ups in the Regulatory World
The Regulatory Insights Workshop is a dynamic and collaborative event designed specifically for start-up companies navigating the complex regulatory landscape. Esteemed speakers with deep expertise in regulatory affairs and compliance will deliver an insightful presentation, covering a range of topics relevant to start-ups. These sessions will address key regulatory challenges, emerging trends, and best practices in various industries.
Speaker profiles:
13:45 - 14:45 Companion Diagnostics Challenges for Pharma and Diagnostic Partners to Work Together
Companion diagnostics and personalized medicine is a rapidly evolving science. The approaches in the US and EU are different and there are overlaps with several other topics.
Speaker profiles:
15:00 - 16:15 Panel Show
The final panel of the day will bring the speakers of the various sessions and sessions back together in some exchange of views and in addressing the questions the audience will have at this stage. The following speakers will join host Gert Bos on stage:
16:15 - 18:30 Networking and Drinks
We end the conference with networking and drinks.
Day 1 | 11 October 2023
Discover the program of day 1.
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Day 2 | 12 October 2023
Discover the program of day 2.
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Day 3 | 13 October 2023
Discover the program of day 3.
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Practical information
We are pleased to welcome you to Novotel Amsterdam Schiphol Airport. Read more information about the hotel, transport possibilities or book your hotel room.
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Speaker information
Our program will be hosted by Qserve’s internal hosts and external speakers from the field. Get to know the professionals from the industry, NBs, and Competent Authorities.
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Register for the event
Join us in Amsterdam on the 11th, 12th, and/or 13th of October.
We look forward to seeing you in Amsterdam in October!
Register now >>