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
Medical device studies usually need more than standard visit forms and adverse event logs. The study record often has to connect a participant, procedure, device model, serial or lot number, operator, implantation or use date, and follow-up outcome in a way that remains easy to review months later. That traceability matters whether the study involves an implantable device, diagnostic device, software-enabled device, wearable, or procedure-based intervention. Capture supports this by letting teams configure structured CRFs around the actual device workflow instead of forcing device data into generic drug-trial forms. A device accountability form can record identifiers and assignment details. A procedure form can capture who used or implanted the device, under what conditions, and whether the procedure followed protocol. Follow-up forms can tie performance endpoints and safety observations back to the same participant and device record. This structure helps monitors and data managers review the study with less cross-referencing. Device identifiers, clinical outcomes, consent records, and safety findings can live in the same clinical dataset with one audit trail, making it easier to answer practical questions such as which device version was used, which participants were exposed, and which events may have been device-related.
Device trials often require careful separation between adverse events, serious adverse events, device-related events, and device deficiencies. A device may fail to perform as intended without causing harm, or a participant may experience an event where the relationship to the device needs investigator assessment. If those records are scattered across spreadsheets, EDC forms, and email threads, the study team can lose the clear timeline needed for monitoring and reporting. With Capture, study teams can create device-specific safety forms that capture event description, onset date, severity, seriousness, relationship to the device or procedure, corrective action, and follow-up status. Device deficiency forms can track the problem, whether the device was returned or replaced, whether the issue affected data quality, and whether additional participant follow-up is needed. Because these forms are part of the EDC, updates are captured with audit history and role-based access rather than sitting in informal trackers. This is especially useful for lean device teams that need a practical safety workflow without buying a large enterprise safety stack before the study requires it. The goal is not to replace the sponsor's regulatory responsibilities; it is to keep the source clinical dataset organized, reviewable, and ready for the team's monitoring, analysis, and submission-support processes.
Medical device consent often needs to explain the device procedure, expected use, possible device-related risks, follow-up schedule, and what happens if the device is removed, replaced, or upgraded. For digital or connected devices, the consent may also need to describe what data is collected, how it is transferred, who can access it, and how it relates to the clinical study record. Capture's eConsent module lets teams keep those consent details inside the same platform as the EDC. Consent versions, signatures, timestamps, and participant records are tied to the study workflow, so the team can see which consent version applied when a participant was enrolled or when a device-related change occurred. If the protocol changes and the consent form is revised, the updated version can be tracked without losing the prior consent history. That same governance model applies to the clinical data captured after consent. Access controls help limit who can view, edit, review, or export study data. Audit trails show changes to forms and participant records. Exports give sponsors a structured dataset for analysis and regulatory preparation, while Enterprise documentation can support the sponsor's validation and qualification process where required.
Overview
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.
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.
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