Define registry scope and design a minimum dataset for a specific device category.
Healthcare & Pharmaceutical Management
Post-Market Surveillance Registries for Medical Devices
Design and run a medical device registry: define the minimum dataset and governance model, link UDI data, detect outlier signals, and generate real-world evidence for regulatory use.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A device safety signal usually surfaces first in registry data, long before it reaches a formal adverse event report, provided the registry was built to detect it. Registry managers and post-market surveillance officers need a minimum dataset that captures the right outcome variables, a governance model that resolves data ownership and consent, and a signal detection method that flags outlier sites or devices without generating constant false alarms. This course begins with registry scope, minimum dataset design and outcome variable selection for a defined device category, then moves into governance, data ownership and consent models appropriate to the registry's legal basis. Data linkage sessions cover connecting Unique Device Identification to registry records and designing case ascertainment and validation methods that keep completeness measurable. Signal detection sessions apply outlier methods such as funnel plots, and evidence sessions cover generating real-world evidence with defensible confounding control. The course closes with regulatory use of registry data and international collaboration, including data harmonisation and sustainable financing models that keep a registry running past its pilot phase.
Expected Learning Outcomes
Establish a governance structure and patient consent model appropriate to the registry's jurisdiction.
Link Unique Device Identification data to registry records for device-level traceability.
Design case ascertainment and data quality assurance processes for registry completeness.
Apply outlier detection methodology to identify sites or devices with elevated revision rates.
Generate real-world evidence from registry data suitable for regulatory or assessment submissions.
Coordinate international registry collaboration and design a sustainable financing model.
Who Should Attend
Clinical registry managers overseeing implant or device outcome registries.
Post-market surveillance officers in medical device manufacturers.
Biostatisticians and epidemiologists analysing registry data for signal detection.
Health technology assessment analysts using real-world evidence from registries.
Hospital data managers coordinating registry data capture and quality assurance.
Regulatory affairs staff using registry evidence to meet post-market obligations.
Course Modules
Select any module to see its sessions and points.
01Registry Design and Governance
2 sessions · 8 points
Session 1Registry Scope and Minimum Dataset Design
- Define registry scope and inclusion criteria for a specific device category, such as joint replacement or cardiac implants.
- Design a minimum dataset that balances clinical value against the reporting burden on participating sites.
- Select outcome variables, including revision, complication and patient-reported outcome measures.
- Pilot the dataset with a small number of sites before wider registry rollout.
Session 2Data Governance and Patient Consent Frameworks
- Establish a governance structure defining data ownership, access rights and steering committee roles.
- Design a patient consent model appropriate to the registry's legal basis and jurisdiction.
- Draft data sharing agreements with participating hospitals, manufacturers and researchers.
- Address secondary use requests for registry data within the original consent and governance terms.
02Data Linkage and Quality
2 sessions · 8 points
Session 1Unique Device Identification Linkage and Data Capture
- Link Unique Device Identification data to registry records to enable device-level traceability.
- Design data capture workflows that integrate with electronic health record and theatre systems.
- Coordinate manual and automated data entry processes to minimise site reporting burden.
- Resolve device identification mismatches arising from labelling or packaging inconsistencies.
Session 2Data Quality Assurance and Case Ascertainment
- Design case ascertainment methods that estimate registry completeness against expected procedure volumes.
- Build data validation rules that flag implausible or missing values at the point of entry.
- Conduct periodic data quality audits comparing registry records against source clinical documentation.
- Establish a data cleaning protocol for resolving duplicate or conflicting patient records.
03Signal Detection and Real-World Evidence
2 sessions · 8 points
Session 1Outlier Detection and Signal Methodology
- Apply outlier detection methods, such as funnel plots, to identify sites or devices with elevated revision rates.
- Set alert thresholds that balance early signal detection against false alarm rates.
- Design an investigation protocol for sites or devices flagged as statistical outliers.
- Communicate outlier findings to sites and manufacturers within an agreed escalation process.
Session 2Generating Real-World Evidence from Registry Data
- Design observational studies using registry data to generate real-world evidence on device performance.
- Apply methods to control confounding when comparing outcomes across non-randomised device cohorts.
- Link registry data with claims or electronic health record data to extend follow-up completeness.
- Prepare registry-derived evidence for submission to regulators or health technology assessment bodies.
04Regulatory Use, Collaboration and Sustainability
2 sessions · 8 points
Session 1Regulatory Use of Registry Data
- Map registry data requirements against EU MDR post-market surveillance and vigilance obligations.
- Prepare registry evidence packages that meet regulatory real-world evidence standards.
- Coordinate registry-based post-market clinical follow-up commitments with device manufacturers.
- Respond to regulatory requests for registry data during a safety signal investigation.
Session 2International Collaboration and Registry Sustainability
- Establish data exchange protocols with international registry collaborations for comparative benchmarking.
- Harmonise data definitions with international consortia to enable cross-registry analysis.
- Design a sustainable financing model combining site fees, manufacturer contributions and public funding.
- Plan registry governance succession and long-term data custodianship arrangements.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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