a CTMS for device trials needs to track signed investigator agreements, monitor sites against the investigational plan, manage deviations and their reporting clocks, check device accountability at every visit, and follow participants for months or years after the procedure. Cloudbyz CTMS is a Salesforce-native clinical trial management system that device sponsors can configure for this, on the same platform as Cloudbyz EDC, eTMF, CTFM and Safety & Pharmacovigilance. It suits MedTech companies of every size, from early-stage developers to global multinationals.
What IDE rules expect of sponsors and sites
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Requirement
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Source
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What the CTMS needs to track
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Signed investigator agreement before participation
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21 CFR 812.43
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Agreement status before site activation
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Monitoring to secure compliance, and action on non-compliance
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21 CFR 812.46
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Monitoring visits, findings, escalation
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Records of device receipt, use and disposition
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21 CFR 812.140
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Device accountability checks at each visit
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Unanticipated adverse device effects reported within 10 working days
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21 CFR 812.150
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Event dates and reporting deadlines
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Emergency deviations reported within 5 working days
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21 CFR 812.150
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Deviation records with dates and clocks
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In the EU, clinical investigations of devices fall under the Medical Device Regulation (Regulation (EU) 2017/745), with its own requirements for sponsor oversight and safety reporting. If monitoring finds an investigator is not complying, FDA rules require the sponsor to secure compliance or stop device shipments and end the investigator's participation, so monitoring findings need a clear trail.
How Cloudbyz CTMS supports device studies
- Start-up: site feasibility, selection and agreement tracking, with Cloudbyz CTFM on the same platform confirming the agreement is executed before activation.
- Monitoring: visit reports built from templates that can include device accountability and procedure checks, with follow-up letters and action items tracked to closure.
- Deviations and issues: each logged with dates, severity and owner, so reporting timelines are visible.
- Safety: device effects can be recorded and reported through Cloudbyz Safety & Pharmacovigilance on the same platform.
- Long follow-up: visit schedules that run for months or years after the implant, with enrolment and follow-up status by site.
- Documents: monitoring records and essential documents linked to Cloudbyz eTMF, which is already used by medical device customers.
Device CTMS checklist
- Agreement status visible before site activation
- Monitoring report template includes device accountability
- Deviations recorded with dates and reporting deadlines
- Device effects linked to safety reporting
- Long-term follow-up visits tracked by site
- Monitoring records filed to the TMF
See a device study in Cloudbyz CTMS
The Cloudbyz team can walk through a device study from site start-up to long-term follow-up. Book a demo or visit cloudbyz.com.
