RAQA Today

Michelle Lott
RAQA Today

Podcast by Michelle Lott

  1. Biocompatibility for MedTech Professionals

    6 DIC

    Biocompatibility for MedTech Professionals

    Everything you need to know about biocompatibility - in one podcast. From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group. 𝗕𝗶𝗼𝗰𝗼𝗺𝗽 𝟭𝟬𝟭: 𝗙𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 By understanding biocompatibility and following best practices, manufacturers can ensure the safety and efficacy of their medical devices: - Biocompatibility involves material selection, device design, testing, and risk management. - Direct and indirect contact with the body are key considerations. - Regulatory requirements and risk assessment are essential. - Material selection can be challenging due to potential adverse reactions. - Device design must minimize the risk of complications. - Testing limitations and regulatory compliance can be complex. 𝗕𝗮𝘀𝗶𝗰𝘀 𝗼𝗳 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 What is assessed, when is it assessed 𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟭 - IEC standard 60601-1 - ISO 14971 - ISO 10993 𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟮 - Testing connector cables for leachables 𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #𝟯 - Intended Use vs Depicted Use - Costs and documentation changes arising from failed biocompatibility testing 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗥𝗲𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗖𝗮𝘀𝗲 𝗦𝘁𝘂𝗱𝘆 #4 - Heat changes chemistry, which means biocompatibility testing 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗘𝘅𝗲𝗺𝗽𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗪𝗵𝗲𝗻 𝗧𝗵𝗲𝘆 𝗔𝗽𝗽𝗹𝘆 𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗕𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗯𝘆 𝗖𝗼𝘂𝗻𝘁𝗿𝘆 - Animal testing - Biocompatibility testing labs - ASCA program 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗗𝘂𝗿𝗮𝘁𝗶𝗼𝗻

    52 min
  2. CE Certification vs FDA Submission Strategy: Which is Right for You?

    1 OCT

    CE Certification vs FDA Submission Strategy: Which is Right for You?

    Which market is best for your product - the EU or the US? The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation. Michelle leads off with a review of FDA strategies and pathways. 15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies. 27:15 - Nika Mendelev explains whether you really need to choose one or the other. 32:10 - the Q+A session begins. Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY

    50 min
  3. ASCA, CLAP, Fraudulent Biocompatibility Data and You

    24 SEPT

    ASCA, CLAP, Fraudulent Biocompatibility Data and You

    Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data. So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.

    30 min
  4. A Conversation with Vistatec's Life Science In-Focus Podcast

    13 MAY

    A Conversation with Vistatec's Life Science In-Focus Podcast

    The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences. We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United States and Europe.

    21 min
  5. eSTAR 5.0 - What You Must Know

    19 ABR

    eSTAR 5.0 - What You Must Know

    This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission. We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly. The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.

    33 min
  6. The Benefits of 3rd Party FDA Reviewers

    12 MAR

    The Benefits of 3rd Party FDA Reviewers

    Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA? I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing questions about using 3rd party reviewers.

    37 min
  7. eSTAR 5.0 Q+A with Patrick Axtell from the FDA

    20 FEB

    eSTAR 5.0 Q+A with Patrick Axtell from the FDA

    Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received. From file size to eSTAR type to biocompatibility - we cover it all.

    34 min
  8. Fractional or Full Time Quality Support: Which is Right for You?

    7 FEB

    Fractional or Full Time Quality Support: Which is Right for You?

    When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring market, and why many companies are opting for fractional QA professionals rather than full-time employees.

    23 min
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Podcast by Michelle Lott

Información

  • Creador
    Michelle Lott
  • Años de actividad
    2021 - 2024
  • Episodios
    47
  • Clasificación
    Apto
  • Copyright
    © All rights reserved
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    RAQA Today

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