Promenade Software provides software regulatory services for Medical Devices. We have years of expertise in FDA and IEC 62304 regulatory submissions, and can help you get through your 510(k), PMA, or MDR/IVDR submission.
Promenade Software provides the full suite of software documentation necessary for your IDE, 510(k), PMA, CE submission, as part of our development services. Our controlled processes are fully FDA 21CFR Part 820, ISO 13485 and IEC 62304 compliant. We have templates for each document required, ensuring full compliance to the associated standards.
If you are doing your own development, our experts can guide you on the software portions of the design history file (DHF), or if you have your DHF, we provide audit services, helping you avoid a costly rejection.
Whether for a custom device or Software as a Medical Device (SaMD) , Promenade Software regulatory services can help you with your submission.
For more on SaMD (Software as a Medical Device), refer to our SaMD specific blogpost.