EDC for Medical Device Clinical Trials

EDC for medical device clinical trials: safety, efficacy, and 21 CFR Part 11–aligned controls in one platform.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

EDC for Medical Device Clinical Trials

Medical device clinical trials evaluate the safety and performance of devices in human subjects. Your EDC must support device-specific endpoints, adverse event and device deficiency capture, consent, and full auditability for FDA and other regulatory submissions. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so medical device study teams can capture high-quality data without enterprise overhead.

Why medical device trials need the right EDC

Medical device studies often involve implant logs, device serial numbers, and device-related adverse events alongside standard clinical data. You need flexible visit and form design, consent with versioning and e-signature, and one audit trail for all data. Legacy EDC built for drug trials may lack device-specific workflows. Capture is built for flexible study designs with controls aligned with 21 CFR Part 11 and HIPAA-aligned security for regulatory and sponsor confidence.

Common medical device trial workflow

Protocol and consent; ethics and regulatory approvals
Site activation and enrollment
Device implantation or use; device tracking and serial numbers
Safety, efficacy, and device deficiency capture; AE reporting
Data review and query resolution
Database lock and export for regulatory submissions

Traditional tool pain points

EDC built for drug trials, not device-specific endpoints
Separate systems for device tracking and clinical data
High cost and long implementation for device studies
Limited flexibility for device deficiency and AE workflows

How Capture supports medical device trials

Unified EDC with eConsent and ePRO; flexible forms for device and clinical data
One platform and one audit trail for all data
21 CFR Part 11–aligned controls and HIPAA-aligned security
Export for analysis and regulatory use; documentation for validation (Enterprise)

EDC for wearable device studies EDC for digital health trials Features

FAQ

Questions we hear a lot

Is Capture suitable for medical device clinical trials?

Yes. Capture supports device studies with flexible EDC, eConsent, and safety workflows. You get 21 CFR Part 11–aligned controls and one audit trail. Many device studies use Capture for early-phase and PMA/510(k) support studies.

Can we capture device-specific data?

Yes. You can design forms for device tracking, serial numbers, implantation dates, and device-related adverse events. All data is captured with full audit history and can be exported for regulatory submissions.

What about compliance?

Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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