A client approached D2R Global Consulting with their ECG analysis and interpretation software, a Class II SaMD, seeking 510(k) clearance from the FDA. The software required a detailed regulatory pathway, including comprehensive documentation, clinical data, and comparisons with predicate devices, to ensure compliance and facilitate a smooth submission process.
The company successfully obtained DSIR certification, officially recognizing their pioneering work in regenerative medicine and therapy. This certification not only enabled them to claim tax incentives for their R&D activities but also enhanced their credibility and positioning as an innovative leader in the field.
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