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To answer your questions about FDA 510k submissions, FDA compliance, or training, please get in touch with us using the calendly links below.

If you need help with your 510k submission, De Novo submission, other regulatory submissions, continuing education training, or QMS auditing for compliance, then please get in touch with Medical Device Academy. We also offer eCopy validation and uploading services if you do not have your own FDA Customer Communication Portal (CCP) account. Often we can answer simple questions at no charge, or we may be able to recommend existing products that provide exactly what you need. If your needs are more complex, we can provide a consulting proposal.