Castor gives medical device teams a compliant, flexible platform to design, collect, and report PMCF data. Castor Catalyst AI-assisted EHR extraction cuts per-chart review costs by 80%. Run the full program in-house, or draw on Castor’s professional services team when you need deeper support.
Trusted by medical device manufacturers worldwide
Manual PMCF chart review runs at $48.75 per chart and 39 minutes of site staff time. Castor Catalyst pulls structured and unstructured data directly from EHRs, maps it to your study database, and returns a confidence-scored output for human review. No manual transcription at the site level.
reduction in per-chart data collection cost (from $48.75 to $9.75)
per-chart review time (vs. 39 minutes with manual data entry)
transcription error rate benchmarked against source EMR data (vs. 6.6% human manual entry baseline)
to launch a PMCF registry (vs. 6-month industry baseline for study setup)
Catalyst pulls structured and unstructured data directly from patient electronic health records and maps it to your study database. Each output is confidence-scored for human review before it enters the study record. No manual transcription at the site level.
For US-based PMCF studies, Catalyst uses FHIR and HIPAA-compliant networks for direct patient data retrieval. Patients authorize remote access without site staff involvement, reducing enrollment and follow-up friction for distributed device populations.
Design data collection forms for any study type, including registry, survey, chart review, and decentralized clinical trials, with no coding required. Forms meet 21 CFR Part 11 validation standards from the start.
Send automated patient surveys at 1, 3, and 5-year follow-up intervals without manual coordination. Castor’s ePRO solutions support multi-language delivery across mobile, tablet, and web. PMCF studies on the platform have collected more than 434,000 patient survey data points to date.
Pull existing patient data from hospital systems via API, reducing manual data entry and improving data completeness. Integration works with major EHR platforms used in medical device follow-up research.
Monitor study progress in real time and export structured data in CSV, PDF, and formats compatible with PSUR and Clinical Evaluation Report workflows. Less manual reformatting before submission.
Castor’s in-house team handles study configuration, eCRF build, query management, and ongoing data review for PMCF studies running on the platform. Teams that need hands-on support can get full data management from setup through audit-ready delivery, at a fraction of what full outsourcing costs.
The electronic data capture system is validated against 21 CFR Part 11, GDPR, and ISO 27001. Audit trails, e-signature support, and role-based access controls are built into the platform architecture.
A PMCF study is complex but the path to compliance is clear. Here is how Castor supports each stage.
Document study objectives, methodology, and data endpoints aligned to your device’s intended purpose and risk classification. Under EU MDR, this follows Article XIV Part B Section 6.2. Other jurisdictions have equivalent planning requirements.
Choose registry, survey, chart review, or decentralized study based on device type and risk class. Higher-risk Class III devices typically require prospective designs with active patient follow-up.
Configure validated eCRF forms using Castor’s drag-and-drop builder. Use pre-built templates or custom forms aligned to your protocol. All forms are version-controlled and audit-ready.
Recruit participants across sites, manage permissions, and monitor data quality in real time. For chart review studies, Castor Catalyst AI-assisted EHR extraction reduces per-chart review time from 39 minutes to 6 minutes, with each extraction confidence-scored for human approval. Query management flags missing or inconsistent data before it becomes a compliance issue.
Export structured data for your Periodic Safety Update Report and Clinical Evaluation Report. Castor dashboards let you track key safety and performance metrics throughout the study lifecycle.
Castor is not a generic EDC adapted after launch. The platform includes PMCF-specific study design templates, PSUR export tools, and Professional Services experience built around medical device post-market requirements.
Registry, survey, chart review, and decentralized clinical trials in a single validated environment. No need to manage multiple tools for different study phases or device types.
Data exports are structured for PSUR and Clinical Evaluation Report workflows. No raw data dumps that require manual reformatting. Reduces the reporting burden on regulatory affairs teams under time pressure.
Configure your own forms, manage your own patients, and own your data throughout the study lifecycle. In-house teams use Castor to stay close to every aspect of their post-market program without depending on external study operations for day-to-day management.
Castor’s in-house team handles study configuration, eCRF build, query management, and ongoing data review for PMCF studies running on the platform. Teams that need hands-on support can get full data management from setup through audit-ready delivery, at a fraction of what full outsourcing costs.
21 CFR Part 11, GDPR, ISO 27001. Audit trails and e-signature support are part of the platform architecture. Also used for real-world evidence studies and clinical trial solutions across device and pharma research.
PMCF studies involving human participants must meet GCP compliance standards under ISO 14155. Castor’s platform is designed to support these requirements without adding separate validation overhead.
Orthopedic implants, cardiovascular devices, neurological tools, wound care consumables, diagnostics, and software as a medical device. Castor’s 343 active PMCF studies span Class I to Class III devices across 132 teams. Whatever you are following up, the platform has handled something comparable.
Castor Catalyst AI-assisted EHR extraction reduces per-chart data collection cost from $48.75 to $9.75 and chart review time from 39 minutes to 6 minutes. Each extraction is confidence-scored for human review before it enters the study record, maintaining the human oversight your QA team and auditors expect.
Numbers from active post-market studies running on Castor today.
PMCF and post-market studies running on Castor, across orthopedic, cardiovascular, neurological, and diagnostic device categories
Medical device teams using Castor to collect and report post-market clinical evidence
Patient survey data points collected through Castor ePRO for PMCF studies
Reduction in per-chart data collection cost via Castor Catalyst AI-assisted EHR extraction ($48.75 to $9.75 per chart)
increase in PMCF study enrollment
requirements fulfilled across active device portfolio
MMI needed to meet EU MDR PMCF requirements while managing significant enrollment pressure across their active medical device portfolio. Their existing data collection approach could not scale to meet the volume and documentation standards required under the new regulation.
After implementing Castor as their PMCF data collection platform, MMI increased study enrollment by 500% while producing the audit-ready documentation required for EU MDR compliance. Castor’s eCRF builder and Professional Services team helped MMI move from protocol design to first patient enrollment significantly faster than their previous approach.
Most device manufacturers hit the same three walls when running post-market clinical studies.
Regulators worldwide require ongoing post-market clinical data. EU MDR Article 61 mandates it for CE-marked devices. FDA post-market surveillance rules demand similar rigor. Spreadsheets and manual processes cannot produce audit-ready data or meet reporting timelines.
Setting up a registry, survey, or decentralized study from scratch takes months. Most eClinical platforms were not built for PMCF-specific data requirements.
Manual EHR chart review is the single largest cost driver in retrospective PMCF and real-world evidence studies. At $48.75 per chart and 39 minutes of site staff time, it limits how many patients you can follow and how often.
A post-market clinical follow-up (PMCF) study is a proactive, ongoing clinical investigation designed to collect real-world evidence on device safety, performance, and benefit-risk balance after market authorization. EU MDR Regulation 2017/745 formally requires PMCF for CE-marked devices, with similar post-market surveillance requirements under FDA regulations (21 CFR Part 822) and other frameworks worldwide. PMCF findings feed directly into Periodic Safety Update Reports (PSURs), Clinical Evaluation Reports (CERs), and equivalent regulatory submissions.
A PMCF study must collect data sufficient to confirm device performance and safety under real-world conditions. This typically includes adverse events, device deficiencies, patient-reported outcomes, clinical outcomes, and device usage patterns. The specific data points are defined in a PMCF plan, which must align with the device’s intended purpose and residual risks identified in the risk management file.
Castor provides built-in dashboards and structured data export tools that allow PMCF study teams to compile and analyze study data in formats suitable for Periodic Safety Update Reports (PSURs). Data can be exported in CSV, PDF, and structured formats compatible with regulatory submission workflows, reducing the manual effort required to translate study data into regulatory documentation.
Yes. Castor’s eClinical platform is validated against 21 CFR Part 11 (electronic records and signatures), GDPR (EU data privacy regulation), and ISO 27001 (information security management). The platform uses audit trails, role-based access controls, and encrypted data storage to meet the applicable regulatory requirements for PMCF and post-market clinical studies, whether under EU MDR, FDA standards, or other frameworks.
Yes. Castor Catalyst uses AI-assisted EHR extraction to pull structured and unstructured data directly from patient records, map it to your study database, and return each output confidence-scored for human review. In internal benchmarking, this reduced per-chart data collection cost from $48.75 to $9.75 (an 80% reduction) and cut chart review time from 39 minutes to 6 minutes per chart. The 0% transcription error rate was benchmarked against source EMR data, compared to a 6.6% human manual entry baseline. Human review and approval remain in the workflow before any extraction enters the study record.
PMCF explained
Post-market clinical follow-up (PMCF) is the ongoing collection and evaluation of clinical data after a medical device reaches the market. It is a regulatory requirement in the EU under MDR Regulation 2017/745 and is increasingly required or expected by other regulators worldwide, including the FDA under 21 CFR Part 822 and equivalent frameworks.
PMCF studies are designed to confirm the safety and performance of a device throughout its product lifecycle, identify emerging risks, and support the Clinical Evaluation Report (CER). They can take several forms, including registries, prospective cohort studies, survey-based follow-up, chart review studies, and decentralized trials.
Under EU MDR, manufacturers of Class IIa, IIb, and III devices must conduct PMCF as part of their Post-Market Surveillance (PMS) plan. The PMCF plan and PMCF evaluation report are submitted as part of the Technical Documentation reviewed by Notified Bodies.
Regulatory certifications
Platform integrations
Learn the full impact of PMCF under the EU MDR and how to best prepare your medical device studies.
Medical device regulations in the EU have recently undergone a major overhaul. Learn the key tenets of MDR by device classification in this fact sheet, and what checklist items must be addressed to be fully compliant.
Castor enhanced enrollment by 500%, increased data returns, and helped MMI fulfill MDR requirements with their PMCF study.