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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), De-Novo, PMA, or MDR/IVDR submission.
Promenade Software provides the full suite of software documentation necessary for your regulatory submission, as part of our development services. Our controlled processes are fully ISO 13485 certified, and the development activities are FDA and IEC 62304 compliant. We implement and document the cybersecurity, making sure your system is secure and documented per FDA requirements.
Even if you are doing your own development, you can purchase our DHF templates for FDA eStar submission. When you purchase our templates, you also receive 4 hours of expert consultation to guide you along the way.
