REDCap Cloud is a validated electronic data capture (EDC) and clinical data management platform for medical device clinical investigations, combining EDC, ePRO/eCOA and eConsent in one 21 CFR Part 11-compliant system. It is built for lean MedTech teams running pilot and feasibility, pivotal (FDA IDE, 510(k), CE-mark) and post-market clinical follow-up (PMCF) studies under ISO 14155 and EU MDR. REDCap Cloud is used by 500+ clinical research organizations across 15,000+ sites
One platform for MedTech. Total control.
MedTech clinical teams are lean by design. Most EDC platforms were built for large organizations with dedicated IT, data-managers, clinical operations and require months to implement.
The platform you choose should match the speed and agility of your team.
Build faster… effortlessly
REDCap Cloud gives medical device teams a single, validated platform to build, collect, and manage trial data. From early feasibility and first-in-human device studies to post-market surveillance, all without the configuration complexity that kills timelines.
One unified platform. All your data.
Your device generates data from sources your EDC was never designed to handle. REDCap Cloud captures eCRF, ePRO, device readings, and lab feeds in one system — with bi-directional data flow that eliminates manual transfers, cuts SDV costs, and gives monitors real-time access to clean data from day one.
Compliance, technology and services to help across the MedTech lifecycle.
Pilot and Feasibility
Everything you need to get your first Pilot live.
- Start capturing data in days with REDCap Cloud’s self-service study builder — no IT team, no dedicated validator required.
- Add ePRO and eConsent modules as your study grows, without switching platforms or re-validating from scratch.
Pivotal
Full compliance and functionality.
- 21 CFR Part 11-compliant, ISO 14155 aligned EDC that supports EU MDR Annex XV investigations and PMCF. Audit trail active from first patient in, not retrofitted before submission.
- Submission-ready CDISC exports, real-time monitoring dashboards, and Safety Gateway AE tracking all on one validated platform.
Post-Marketing Surveillance and PMCF
- Run PMCF data collection under EU MDR and post-market surveillance through the same platform you used for your pivotal study; without migration or revalidation.
- Run multiple PMCF studies simultaneously with flexible study templates and shared site networks.
- Real-world evidence collection built in with wearable integrations, patient diaries, and ePRO without adding vendors.
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Start your journey with REDCap Cloud today – scale for tomorrows novel therapies.