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    SAFEGUARDING YOUR eIFU SINCE 2008

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    Maurizio Suppo
    Author

    Maurizio Suppo

    Principal Consultant IVD - Regulatory Affairs

    35+ years of experience in IVD & Medical Device Regulations

    Maurizio is a veteran in IVD and Medical Device Regulations with over 35 years of industry experience. As Principal Consultant, he provides strategic guidance on regulatory strategy, Notified Body interactions, and complex compliance challenges across global markets.

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    Articles by Maurizio

    What Do Notified Bodies Expect of Your eIFU Solution and Its Implementation?
    Compliance
    EU MDR

    What Do Notified Bodies Expect of Your eIFU Solution and Its Implementation?

    Implementing an eIFU solution has major implications on your QMS. Learn what Notified Bodies will review during the process.

    Feb 7, 20248 min read
    Privacy and Compliance in the Medical Industry: How Firms Can Walk the Tightrope
    Security
    Compliance

    Privacy and Compliance in the Medical Industry: How Firms Can Walk the Tightrope

    Recent changes in eIFU regulations have changed the way medical device firms operate. Learn how to balance privacy and compliance using eIFU innovations.

    Oct 30, 20236 min read
    European Parliament Regulation 2021/2226: Everything Medical Professionals Need to Know
    EU MDR
    Compliance

    European Parliament Regulation 2021/2226: Everything Medical Professionals Need to Know

    Changes to eIFU regulations mean any evolution in IFU must be made clear to end users. Companies need to think of eIFU systems as active communication channels.

    Oct 30, 20235 min read
    eIFUs: Why Electronic Instructions Are Just Part of the Package
    Implementation
    Compliance

    eIFUs: Why Electronic Instructions Are Just Part of the Package

    The benefits of eIFU extend far beyond electronic instructions, offering wide-ranging opportunities in other essential business services.

    Oct 30, 20235 min read
    IFUcare Integrates EU's Implementing Regulation 2021/2226 on eIFU for Medical Devices
    EU MDR
    Compliance

    IFUcare Integrates EU's Implementing Regulation 2021/2226 on eIFU for Medical Devices

    The European Commission has updated rules governing eIFU for medical devices. Learn how IFUcare has integrated these changes.

    Oct 30, 202310 min read
    The Impact of Implementing an eIFU Solution on Your Quality Management System
    Implementation
    Compliance

    The Impact of Implementing an eIFU Solution on Your Quality Management System

    In Europe, manufacturers of certain categories of medical devices can replace paper IFU with an electronic version. Learn about the impact on your QMS processes.

    Oct 30, 20238 min read

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