The Clinical Data Platform Medical Device Teams Run From First-In-Human To Post-Market

Lean device teams still have to produce evidence that satisfies EU MDR and FDA, and the work rarely ends at approval. Multi-year follow-up, PMCF obligations, and source documents that arrive as surgical notes, EMR screenshots, and paper worksheets all add weight. This offering combines EDC, ePRO, and eConsent in one validated environment, with AI-driven extraction, human review, and an in-house data management team. Platform figures span 900+ device studies, including a 0.8% manual override rate on structured source forms in one live extraction study, set against a 6.6% manual transcription baseline. Customer results from MMI and Sword Health are also included. Discuss how your own device trial could be set up.