We help Medtech companies create and clear Software as a Medical Device (SaMD). We can develop a regulatory strategy, build your software (AI/ML, web, native, and cybersecurity), draft your design documents, and handle your FDA 510(k) submission. Click here to learn more.
The Hemodynamic Waveform IOD is the specification of digitized pressure, electrical, and other signals from the patient circulatory system, which has been acquired by a hemodynamic modality.