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Xtalks, Online
2024-10-02
Is a team designing a medical device and seeking guidance on product safety regulatory requirements? Is there a need to integrate off-the-shelf components into the device or will the manufacturer design and test the devices on their own? Either option necessitates understanding the standards and regulatory requirements of bodies such as the United States Food and Drug Administration (FDA).
Medical devices need to address differences between basic safety, essential performance and intended use. There are different requirements and standards for various functions, many of which need different types of testing. It can be challenging to navigate these complex requirements and to understand which requirements take precedence. This webinar is designed to help simplify this process.
Would less regulatory pushback accelerate the time to market? Is there an interest in acquiring more knowledge and guidance for this process? In this webinar, the expert speaker will discuss basic safety and essential performance requirements under the IEC 60601 series as well as the challenges in integrating power supplies and batteries into a medical device.
Join this webinar to learn about product safety for medical devices. The expert speaker will cover best practices when designing a medical device, which will help create a path to ensure a smooth regulatory process. In the USA, medical devices need to meet both Occupational Safety and Health Administration (OSHA) Nationally Recognized Testing Laboratory (NRTL) and FDA requirements, and this webinar covers how to achieve this goal.
Register for this webinar today to enhance your understanding and expertise in medical device regulation and product safety compliance.
Keywords: Medical Device, Regulatory, Medical Device Regulation, Medical Device Manufacturing, Commercial Manufacturing, Medical Device Development, Quality
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Organized by:
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Xtalks |
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Invited Speakers:
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Bob Burek, Product Safety Technical Manager, Connected Technologies and Mobility, Element Materials Technology
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Deadline for Abstracts:
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2024-10-02
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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