Genius Shield’s Post

Brilliant Innovators, Yes, yes, and one more time for good measure... YES! You need a Quality Management System (QMS)! I have been asked this question so many times and seen it in so many forums... 🤦🏻♀️ If you are developing a Medical Device, as defined by the FDA, you will need a QMS. ✅ Even if your external contract manufacturers and suppliers have one, that's STILL not enough! Why? Because YOU and ONLY YOU are ultimately responsible as the manufacturer. You can learn more about why a QMS is so critical here: https://lnkd.in/dDfxBAxX Know someone developing a medical device? SHARE this post with them too! 👍 #GeniusShield #medicaldevices #biomedicalinnovation #FDA #changetheworld #Femtech #medicaldeviceregulation #productdevelopment #medicaldeviceinnovation #technicaldocumentation #regulatorysubmission #regulatorystrategy #QMS #qualitymanagement #qualitymanagementsystem

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