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  • The short answer is yes, most states require an annual license to market medical electrical devices. Often it is a spin-off of their requirement for pharma companies to sell their drugs. This is normally taken care of by your local distributor. If you sell directly, then you will need a license. The regulations are evolving all the time so ...

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    RE: Hello!

    Hello-- I was curious to know if the study group has been established?  I would be interested in participating. I too have some re-certification that needs to be done.  Thanks, ------------------------------ Amy Senior Quality Engineer Riverton UT United States ------------------------------

  • Hello, As per the the FDA guidance "Refuse to Receive standards" (Page 10) In-house methods used in lieu of USP methods should be compared to the USP method to support a demonstration that the in-house method is sufficient.  Thanks, Mehul ------------------------------ Mehul Govani RAC Regulatory Affairs Manager Westbury NY United States ----- ...

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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