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Thank you so much Richard for the valuable feedback. ------------------------------ Bhupinder Singh QA/RA Manager (RAC) San Jose CA United States ------------------------------

Hello RAPS Community, I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, ...

We are hiring a Regulatory Affairs Director role at Akili Interactive. Please reach out to me if anyone is interested in this role. if you love establishing and maintaining comprehensive regulatory strategies that support cutting-edge digital therapeutics products, processes, and services through the ...

Hi, I have a few questions regarding EU MDR.  (1)    If the CE marked product is not marketed commercially in EU, do we still need to designate an importer? I think the answer is "NO" as the organization is not distribute their product commercially (2)    Similarly, is a designated distributor ...

Yes, Commercial invoice for the software Thanks, ------------------------------ Bhupinder Singh QA/RA Manager (RAC) San Jose CA United States ------------------------------