EPISODE · Dec 22, 2025 · 48 MIN
Episode 54 - Medical Devices
from Intro to Clinical Research · host Debbie and Elyse
Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!) Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents https://www.fda.gov/media/82395/download https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements https://hollandhoudek.com/implants
What this episode covers
Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!) Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents https://www.fda.gov/media/82395/download https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements https://hollandhoudek.com/implants
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Episode 54 - Medical Devices
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