Webinar

Product Safety Compliance for Medical Devices according to the IEC 60601 series

bob burek

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Bob Burek

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Bob Burek is a Product Safety Technical Manager at Element with over 30 years of experience in evaluating devices for product safety and regulatory compliance.

This webinar guides medical device manufacturers through key safety and regulatory requirements, including FDA and IEC 60601 standards.

Key topics and takeaways:

Highlights of this webinar include:

    • Product Safety requirements for medical devices
    • What is Essential Performance and how to identify it
    • Key test and construction requirements
    • How to integrate a power supplies and battery packs in medical devices

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