Contact us for help with your FDA 510k or De Novo submission

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

If you need help with your 510k submission, other regulatory submissions, continuing education training, or QMS auditing for compliance, then please contact 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.

How to contact Rob Packard

Phone: +1.802.281.4381

E-mail: rob@13485cert.com

Try one of the calendly links below to schedule a call with me: