MDRChats-by ChatMDR

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MDRChats-by ChatMDR Podcast

MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.

Episodes

  1. Sufficient levels of access to data needed to justify claims of equivalence

    JUL 5

    Sufficient levels of access to data needed to justify claims of equivalence

    In this episode of MDR Chats, host Oliver Harris interviews an expert about the MDCG 2023-7 guidance document. They discuss the concept of ‘sufficient levels of access’ to data needed to justify claims of equivalence for medical devices, exploring the types of data required, methods of demonstrating access, and the implications for manufacturers. This episode provides essential insights into ensuring compliance with EU medical device regulations and maintaining high standards of safety and performance.

    9 min
  2. Guidance on Standardisation for Medical Devices - Rev 1, Published July 2024

    JUL 2

    Guidance on Standardisation for Medical Devices - Rev 1, Published July 2024

    Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Thompson about the latest revisions in standardisation for medical devices. Stay updated with essential insights on the new MDCG document published in July 2024, including key differences and implications for compliance in the medical device sector. Tune in for expert guidance and practical advice.

    13 min
  3. Clinical evaluation of orphan medical devices

    JUN 30

    Clinical evaluation of orphan medical devices

    Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Collins about the clinical evaluation of orphan medical devices. Discover the unique challenges and considerations in developing, testing, and regulating devices for rare conditions. Perfect for professionals and enthusiasts in the medical device field.

    21 min
  4. Risk-Based Statistical Sampling Plan

    MAY 4

    Risk-Based Statistical Sampling Plan

    A risk-based statistical sampling plan for medical devices adjusts sample sizes and testing criteria according to the potential impact of failures, guided by historical data and risk assessments. This method efficiently ensures product safety by matching testing intensity to the severity of possible risks

    10 min
  5. A Deep Dive into Medical Device Deadlines

    APR 22

    A Deep Dive into Medical Device Deadlines

    In this podcast, regulatory experts discuss the extended deadlines under the Medical Device Regulation (MDR), focusing on the transitional periods for various classes of medical devices.

    6 min
  6. The Significance of the EU AI Act for Medical Devices

    MAR 24

    The Significance of the EU AI Act for Medical Devices

    In this episode of MDR Chats, we delve into the intersection of artificial intelligence and medical device regulation under the new EU Artificial Intelligence Act. This episode is created by chatMDR.eu . The voices in this podcast are AI-generated.

    5 min
  7. Person Responsible for Regulatory Compliance, PRRC

    MAR 17

    Person Responsible for Regulatory Compliance, PRRC

    Better understanding of the PRRC's role, responsibilities, and operational considerations for manufacturers and other economic operators. The voices in this podcast are AI-generated.

    6 min

  8. MAR 17

    MDRChats | Official Trailer

    MDRChats is your go-to podcast for the latest insights and updates on Medical Device Regulation, tailored for those with busy schedules. Our episodes are designed to enhance your understanding of MDR, keeping you informed and ahead in a rapidly evolving field. Subscribe to MDR Chats and effortlessly learn more about Medical Device Regulation.

    28 sec

Trailer

About

MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.

Information

  • Creator
    ChatMDR
  • Years Active
    2K
  • Episodes
    8
  • Rating
    Clean
  • Copyright
    © ChatMDR
  • Show Website
    MDRChats-by ChatMDR

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