FDA-Ready Post-Market Surveillance Studies | 522 Orders, PMCF & Real-World Evidence
Post-market surveillance isn't passive monitoring—it's structured evidence collection that FDA expects to answer specific safety and effectiveness questions. We design 522 study protocols, PMCF plans, registry frameworks, and real-world data strategies that meet regulatory requirements and deliver actionable insights.
Why Post-Market Surveillance Programs Fail
Most surveillance failures aren't "bad data"—they're strategic gaps: unclear study objectives, endpoints that don't match FDA's questions, data collection tools that miss critical events, analysis plans without statistical rigor, and reporting timelines that slip. We help you build surveillance programs that answer the right questions with defensible methods.
- Clear objectives: surveillance questions aligned to FDA's safety/effectiveness concerns and approval conditions.
- Appropriate endpoints: clinical outcomes, device performance metrics, and adverse event definitions that capture what matters.
- Practical data collection: case report forms, registries, or electronic systems that clinicians will actually use.
- Statistical rigor: sample size justification, analysis plans, and interim monitoring that support valid conclusions.
Post-Market Surveillance Programs
Structured programs that deliver credible evidence—and satisfy FDA requirements on time.
522 Study Protocol Development
Typical range: $15,000–$50,000
For devices under 522 postmarket surveillance orders needing FDA-compliant study protocols and timelines.
- Study objectives, endpoints, and design aligned to 522 order requirements
- Sample size calculation, enrollment strategy, and follow-up schedules
- Data collection tools, adverse event definitions, and statistical analysis plan
PMCF Planning & EU MDR Compliance
Typical range: $12,000–$40,000
For companies needing post-market clinical follow-up plans that satisfy EU MDR requirements and FDA expectations.
- PMCF plan structure: objectives, methods, data sources, and update schedule
- Literature review protocols, clinical evaluation integration, and trend analysis frameworks
- Coordination with quality system, vigilance, and periodic safety update reports
Registry Design & Real-World Evidence
Typical range: $20,000–$80,000+
For programs needing structured registries or real-world data strategies to support safety claims and label expansions.
- Registry framework: governance, data elements, enrollment criteria, and site engagement
- Electronic data capture system selection and case report form design
- Real-world evidence strategy: claims data, EHR integration, or patient-reported outcomes
Surveillance Execution & FDA Reporting
Typical range: $10,000–$60,000+
For teams needing ongoing study management, data monitoring, interim reports, and final submission packages.
- Site activation, enrollment tracking, and data quality monitoring
- Interim analysis execution, safety monitoring, and protocol amendments
- Final study reports, FDA submission packages, and post-report Q&A support
Who We Help
522 Order Compliance
Devices with active 522 postmarket surveillance orders needing protocol development and timely study execution.
High-Risk Device Monitoring
Class III or high-risk Class II devices requiring structured surveillance beyond routine complaint systems.
Novel Technology Assessment
First-in-class or novel mechanism devices needing real-world performance data to confirm safety and effectiveness.
EU MDR PMCF Requirements
Companies needing compliant PMCF plans and clinical evaluation updates for EU market access and maintenance.
Label Expansion Support
Teams using post-market data (registries, RWE) to support new indications, populations, or claims.
Long-Term Safety Studies
Implantable or durable devices requiring multi-year follow-up to characterize late-onset complications or failures.
How We Run Surveillance Engagements
We design surveillance programs that deliver credible answers to FDA's questions—on timeline and on budget.
Objectives & Endpoints
We clarify surveillance questions, define clinical endpoints, and align study design with FDA expectations and approval conditions.
Protocol & Data Tools
We develop protocols with appropriate controls, sample sizes, and data collection instruments that sites can execute reliably.
Enrollment & Monitoring
We manage site activation, track enrollment, monitor data quality, and conduct interim analyses per protocol requirements.
Analysis & Submission
We complete statistical analysis, prepare final study reports, and package submissions that satisfy FDA reporting obligations.
Post-Market Surveillance FAQs
What's the difference between 522 studies and routine post-market surveillance?
522 studies are formal FDA orders requiring specific protocols, endpoints, and timelines to answer safety/effectiveness questions. Routine surveillance includes complaint handling, MDR reporting, and trending—both are required but serve different purposes.
How long do 522 studies typically take?
It depends on enrollment requirements and follow-up duration. Protocol development takes 2-4 months, enrollment can take 6-24 months depending on patient availability, and follow-up adds 1-5 years. FDA provides specific timelines in 522 orders.
Can we use existing registries or real-world data sources?
Sometimes. If an existing registry captures your device, relevant outcomes, and sufficient follow-up, it may satisfy surveillance requirements. FDA prefers prospective data collection but will consider validated retrospective sources.
Are these pricing ranges fixed?
No—these are typical working bands. After a triage call we provide a fixed or milestone quote based on study complexity, enrollment targets, follow-up duration, and whether you need design only or full execution and reporting support.