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Anon, Usually it takes 2 to 3 weeks if everything is fine - international companies sometimes can take a bit longer because of providing tax information. Sometimes they do come back with clarification or request for further information. ------------------------------ Richard Vincins ASQ-CQA, MTOPRA, ...

Hello Anon, Indeed the questions being asked are quite broad and might want to seek some specific training or obtain expert support. Typically foreign establishment inspections by US FDA are notified 2 to 3 months in advance which is quite helpful in preparing and planning. Though note, the company ...

Hello Anon, You can get information concerning the IDE process here: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process. Basically an IDE is approved at Day 30 unless FDA notifies the Sponsor/Submitter of issues or concerns. In my experience, FDA does notify ...

Thanks for bringing that up Roger - the REdI annual conference is really nice, can attend online, and it is free ! Indeed, I am sure that will be a topic on the agenda this year. ------------------------------ Richard Vincins ASQ-CQA, MTOPRA, RAC Principal Strategy Consultant NAMSA --------------- ...

Anon, There are number of different formats and structures which can be used generating a usability document for an existing product. While an HFE factors assessment or Usability Study does not necessarily need to be performed - an "assessment" from a usability perspective is quite helpful to generate ...