What does the AI Act mean for you?

What will the AI Act mean for medical devices and/or digital health systems? What are possible conflicts between the AI Act and the MDR / IVDR? Should you prepare for the Artificial Intelligence Act and how?

Jos van der Wijst is driven by the Interest in emerging technologies and their legal framework. Use creativity to find an answer when the answer isn’t there yet.

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E-health and MDR: Lessons learned from International projects

Developing E-health applications is one speciality, taking into account MDR and GDPR is a second key challenge. A lesson learned from our international projects. You also need CE marking as well as knowledge of healthcare reimbursement systems. The reimbursement differs from country to country. This presentation gives a practical overview of lessons learned and looks to the future: what are the new opportunities and where are threats.

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From Clinical Innovation to the Market

Choices of a StartUp to Navigate the current Regulations

Fitting a promising innovative technology into solving a relevant clinical problem requires many critical choices to consider early on.

Based on a real-world example in measuring cardiac output in heart patients, Arthur Bouwman, cardio-anaesthesiologist and co-founder of a medical device start-up, and Claus Schaffrath, partner at a medical device consultancy, describe clinical and regulatory choices, and their consequences for bringing a medical device to the market.

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Medical Device Development in the EU: Be prepared for the Queue!

An introduction in Medical Device Development in Europe, starting with the explanation of roles & regulations and do’s and dont’s in order to get your device on the market.
Followed by an overview of the current situation in the field regarding certification of medical devices and the queues at Notified Bodies.
Closing with some tips to be prepared!

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MDR: a Notified Body perspective and beyond.

Notified Bodies are a key player in the implementation of MDR. Acting as the main agents of Europe and the local Competent Authorities, we are at the forefront of the changes, in our case the new MDR and Brexit, that need to allow the industry to keep and bring Medical Devices to the European market.
This is a daunting task which needs to be finalized by May 2024 with the majority of the work still laying ahead of us.

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Impact of MDR on European SMEs system

The new regulation concerning Medical Devices (2017/745) and Diagnostics (2017/746) could have a dramatic impact on SMEs system. Right now, only a small amount of manufacturers are in compliance to the certification processes of the new Regulation. The risk in here is a shortage of Medical and Diagnostics Devices, that can have an effect on European Sanitary Systems, and on the health needs of the patients. How should we handle this challenge? This is the real question about our future. What about MDR and Telemedicine?

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From Clinical Innovation to the Market

Choices of a StartUp to Navigate the current Regulations

Fitting a promising innovative technology into solving a relevant clinical problem requires many critical choices to consider early on.

Based on a real-world example in measuring cardiac output in heart patients, Arthur Bouwman, cardio-anaesthesiologist and co-founder of a medical device start-up, and Claus Schaffrath, partner at a medical device consultancy, describe clinical and regulatory choices, and their consequences for bringing a medical device to the market.

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From vision to mass production

Conventional ambulatory ECG monitors, while accurate, offer a poor wearability experience as they rely on the use of wires and/or patches. New wearable technologies, implementing wireless electrode systems, have improved wearability, increasing patient satisfaction, but not yet resolved the problem.
How to go from vision to FDA 510k-cleared for a novel non-invasive, patchless, wireless Holter monitor (QardioCore, by Qardio, Inc.).

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The added value of a dedicated supplier for health care applications – Sustainability, an innovative challenge in healthcare

Describing the current status of the industry in methods, materials, challenges and solutions. The rules and regulations become even more strict for any new healthcare application to comply to. This could cause reluctance to involve sustainability in the requirements, but this step is needed to keep track and be prepared for the near future. Albis shows the current landscape.

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