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Intro to Clinical Research

Episode 54 - Medical Devices

49 min22 december 2025

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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