AI ACT Summit 2024

    Following the announcement of the AI ACT publication, we wanted to organize the first AI ACT Summit so people can better understand the impact of this new legislation on the Medical Device Industry.

    We will provide you with more information soon. If you are already interested in being part of it, don’t hesitate to contact us at info@easymedicaldevice.com

    Below you can find the agenda and also directly purchase your place.

    4BetterDevices and Easy Medical Device organize this Event.

    Event Details
    Tickets
    Early Birds (Before July 31st 2024)
    450 €

    Conference entry for the full day
    Breaks (Beverage and sweets)
    Lunch (Buffet)

    Speakers
    Soufiane Zakaria AZDAD
    CEO
    Algoscope
    Soufiane Zakaria AZDAD is the CEO and Co-founder of Algoscope, an innovative startup focused on transforming laboratory medicine. An out-of-the-box thinker who grew up in the hood, Soufiane has shown remarkable resilience and determination throughout his journey. Married since the age of 19 and a father of three, he has successfully managed to complete medical school, a residency in Pathology, and earn a diploma in Quality Assurance, all while founding his startup. Currently, Soufiane is at the forefront of designing and manufacturing an innovative device aimed at revolutionizing laboratory medicine. His unique background and drive exemplify his commitment to making a significant impact in the medical field.
    Richie Christian
    Medical Device Consultant
    wega Informatik AG
    Richie Christian is a creative regulatory and quality leader with a distinctive blend of experience in traditional hardware medical devices and cutting-edge AI/ML-enabled software. He possesses a pragmatic understanding of quality and regulatory requirements, ensuring the development and marketing of safe, effective, and compliant medical devices. Richie's expertise allows him to balance regulatory demands with business objectives and stakeholder expectations, making him a valuable asset in the medical device industry.
    MARIA DIEZ
    QA/RA Consultant for MD and IVD. Specialist in MDSW and AI
    CMG MedDev consultancy
    Maria Diez holds a PhD in Biochemistry and Molecular Biology and is highly committed to Quality Standards, Good Clinical Practices, and MD and IVD regulations. She is proficient in developing and maintaining Quality Management Systems (QMS), handling both daily routine tasks and the overall strategic vision of the QMS. Maria regularly conducts reviews, internal audits, and follow-ups to ensure compliance and continuous improvement within the QMS framework.
    Gert Bos
    CEO
    Qserve
    Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting. He is a president-elect and member of the Board of Directors of RAPS, founding member of the Board of Directors of RAPS Europe and a founding board member of the Dutch RAPS Chapter. Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR.
    Florian Tolkmitt
    CEO
    PRO-LIANCE GLOBAL SOLUTIONS GmbH
    Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs, and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance, and risk management and he is also an assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, which works on an open-source data model for Technical Documentation.
    Fabrizio Maniglio
    Director, Industry and Business Development
    Honeywell
    Fabrizio Maniglio is an experienced and highly motivated QA Leader with excellent communication skills and a strong affinity for IT systems. He is dedicated to providing the best quality service to both internal and external customers by building and leading high-performing cross-functional teams. Fabrizio excels in developing and inspiring people to become change catalysts within the organizational matrix.
    Cyrille Michaud
    Co-founder and Managing Partner
    MD101 Consulting
    Cyrille Michaud is the Co-founder and Managing Partner of MD101 Consulting. He is a distinguished consultant specializing in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices. His expertise spans a wide range of regulatory standards and frameworks, including CE Mark & FDA 510k, 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, IEC 82304-1, UL 2900-1, and IEC 81001-5-1. Cyrille is adept in managing software processes and applying Agile methods to medical device software design. He is also proficient in implementing cybersecurity measures for medical devices.
    Fabien Roy
    Partner (EU pharma/device)
    Hogan Lovells
    Fabien Roy is an EU pharma/device lawyer specializing in European Union regulatory matters for medical devices and pharmaceuticals. He closely monitors new regulations like the MDR, IVDR, and GDPR, advising clients on digital health technology requirements. Fabien's expertise covers various stages of the medical device CE marking process, including: Product classification Clinical investigation procedures Drafting clinical investigation, clinical trial, distribution, and contract manufacturing agreements Clinical data requirements and evaluations Conformity assessment procedures Reviewing Instructions For Use, product labeling, and promotional materials Post-marketing surveillance activities Preparing and reviewing technical documentation Reimbursement He also advises on marketing authorization procedures, clinical trials, and promotional activities in the pharmaceutical sector, specializing in the regulation of medical devices and medicinal products in the EU.
    Cesare Magri 4BetterDevices
    Cesare Magri
    CEO
    4BetterDevices
    Monir El Azzouzi
    CEO
    Easy Medical Device
    Thomas Lommatzsch
    Head of the Medical Business Unit
    AFNOR Certification
    Map
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