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Hi Folks, I am working for a medical Device company. We manufacture Class III Product. My Company manufactures a Class III medical device that is currently under an IDE clinical trial in the US. The company has outgrown its current location and wishes to close its current manufacturing facility and ...

My company manufactures a Class III medical device that is currently under an IDE clinical trial in the US. The company has outgrown its current location and wishes to close its current manufacturing facility and move all manufacturing operations to a nearby city. Due to OUS demand, the business cannot ...

Hello all, What are the contents of the Risk Management File in a medical Device and how FMEAs differs from Risk management File? How is Risk Managed and captured in documentation.

I wonder i have the same form. would you like to share the form you received from FDA? Thanks ------------------------------ Devang Barot

I have requested one as well on 1st February but it resulted into the reply as they are not accepting the application for class II device. Can you please specify what exactly you mentioned in your email for submitting GUDID account request. Thanks ------------------------------ Devang Barot MS ...