PMS Plan Execution
PMS plan execution tracks the activities, sources, and frequencies the plan commits to, since an unexecuted plan is a documented gap rather than a defense.
Custom Software
Medical Device Post-Market Surveillance Software Development
Post-market surveillance software executes the systematic monitoring a PMS plan requires: collecting real-world performance data, monitoring literature and registries, detecting trends against defined thresholds, and supporting periodic reporting. It differs from complaint handling by being proactive, since surveillance looks for signals rather than responding to reports that arrive.
Complaint handling is reactive by design. Post-market surveillance is the obligation to look actively, and under EU MDR that obligation is explicit and documented. Taction Software builds medical device post-market surveillance capability that executes a PMS plan rather than producing reports about complaints that happened to arrive.
Tell Us Your Requirements
Our experts are ready to understand your business goals.
Trusted Partners
Trusted by Industry Leaders Worldwide
Recognition
Awards & Recognitions
What Is Post-Market Surveillance Software
Medical device post-market surveillance software supports systematic collection and analysis of device performance data after market entry: executing the PMS plan, gathering post-market clinical follow-up data, monitoring published literature and registries, analyzing complaint and service trends against thresholds, and assembling periodic safety reports. Where complaint systems process what arrives, surveillance actively seeks evidence about how the device performs in real use. Our work sits within our broader medical devices and IoT practice.
PMCF Data Collection
Post-market clinical follow-up gathers clinical performance evidence through studies, registries, and structured data collection where required.
Trend Detection
Trend analysis compares complaint and malfunction rates against defined thresholds, triggering review when statistically or clinically significant.
Literature Monitoring
Literature surveillance monitors publications mentioning the device or device type, since published findings constitute surveillance input requiring assessment.
Registry and Real-World Data
Registry evidence draws on our clinical registry software development work for longitudinal outcome data collection.
Periodic Report Assembly
Periodic reporting including PSUR assembles surveillance findings, with medical writing and conclusions produced by qualified personnel.
Core Post-Market Surveillance Services
Our medical device post-market surveillance services cover plan execution tooling, data collection, trend analytics, literature workflow, and periodic reporting support. The gap we most commonly find is between the written PMS plan and what actually happens, since plans commit to activities that nobody scheduled or tracked. Engagements typically open with a comparison of documented plan commitments against evidence those activities occurred.
01
PMS Plan Tooling
We build plan execution tracking so committed activities have owners, schedules, and evidence, closing the gap between plan and practice.
02
Data Source Integration
Integration spans complaints, service records, registries, and clinical sources, drawing on our real world evidence platform work.
03
Trend Analytics
Threshold monitoring compares rates against defined limits, with review triggered by exceedance rather than by periodic manual inspection.
04
Literature Screening
Literature workflow screens publications with relevance assessment, drawing on our clinical NLP development practice for screening support.
05
Risk File Continuity
Surveillance findings feed risk management, connecting with our risk management software work on risk file updates.
06
Validated Delivery
Surveillance records support regulatory obligations. Our 21 CFR Part 11 for AI work covers audit trails and validation.
Benefits of Purpose-Built Surveillance Software
The benefits concentrate in demonstrable plan execution, earlier signal detection, and reduced periodic reporting effort. PMS deficiencies are a common notified body finding, usually because the plan committed to activities the organization could not evidence performing. We publish no figures on signal detection, reporting efficiency, or audit outcomes, because those depend entirely on portfolio, device risk class, and current process maturity.
Demonstrable Plan Execution
Activity tracking evidences that committed surveillance actually occurred, which is what notified bodies examine rather than the plan document alone.
Earlier Signal Detection
Threshold monitoring surfaces rate changes as they develop rather than at periodic review, when the pattern may already be substantial.
Reduced Reporting Effort
Data assembly for periodic reports draws on maintained records rather than retrospective collection, leaving writing to qualified personnel.
Complete Literature Coverage
Systematic screening covers publications consistently, addressing the gap where literature monitoring happens sporadically when someone remembers.
Risk File Currency
Surveillance findings keep the risk file current, since post-market evidence is supposed to inform risk assessment continuously rather than at renewal.
Complaint Continuity
Surveillance connects with reactive reporting, complementing device adverse event workflow for complete safety coverage across both directions.
Our Post-Market Surveillance Process
We deliver medical device post-market surveillance projects in gated phases so quality, regulatory, and clinical stakeholders approve direction before engineering cost accumulates. Discovery compares documented PMS plan commitments against evidence of execution, since that gap defines what the system must close. Threshold definition is done with quality and clinical input, because thresholds set too tight generate noise and too loose defeat the purpose.
Discovery and Plan Gap Analysis
Discovery compares plan commitments against execution evidence, since the gap between the two is the finding notified bodies most reliably identify.
Data Source Mapping
We map available surveillance sources including complaints, service, registries, and literature, since coverage determines what signals can be detected.
Threshold Definition
Thresholds are set with quality and clinical input, balancing sensitivity against noise, since neither extreme produces useful surveillance.
Workflow Development
Development builds activity tracking and review workflow, so surveillance findings route to assessment rather than accumulating in a report.
Reporting Support
Periodic report assembly is built to draw on maintained data, with conclusions and medical writing produced by qualified personnel.
Rollout and Ongoing Support
Rollout expands by product family with execution monitoring and continuing support as portfolios and regulatory expectations change.
Technology and Compliance
Post-market surveillance operates under FDA requirements including postmarket surveillance studies where imposed, EU MDR obligations covering PMS plans, PMCF, and periodic safety update reporting, and quality system expectations connecting surveillance to risk management. Taction holds ISO 27001 certification. The point worth emphasis is that surveillance is proactive: the obligation is to look systematically, and evidence of looking is what audits examine rather than the absence of findings.
PMS Plan Obligations
PMS plans commit to specific activities and sources, and evidence of execution is examined rather than the plan document being sufficient alone.
PMCF Requirements
PMCF obligations require clinical evidence gathering where existing data is insufficient, which is a data collection commitment rather than analysis alone.
Periodic Reporting
Periodic safety reporting frequency varies by risk class, with content requirements defined rather than left to sponsor discretion.
Trend Reporting Thresholds
Threshold exceedance may itself carry reporting obligations, so threshold definition has regulatory as well as operational significance.
Signal Versus Causality
A surveillance signal indicates a pattern warranting assessment. Causality and clinical significance are determined by qualified personnel.
Deployment Security
Deployments run in your cloud tenancy or hybrid, with network segmentation, signed container images, and documented penetration testing before release.
Why Choose Taction Software
Taction Software was founded in 2013 and has spent over 12 years building healthcare and life sciences software, delivering more than 200 healthcare projects from four US offices in Chicago, Cheyenne, Austin, and Sacramento, with ISO 27001 certification. Our relevant focus here is closing the gap between the written plan and actual execution, which is where PMS findings originate far more often than in analysis quality. Our leadership brings more than 20 years of personal experience in the field.
01
Plan Execution Evidence
We build activity tracking against plan commitments, since notified bodies examine whether committed surveillance actually happened.
02
Proactive Rather Than Reactive
We design for systematic looking rather than processing what arrives, which is the distinction between surveillance and complaint handling.
03
Established Healthcare Focus
Founded in 2013, we have concentrated on healthcare and life sciences rather than treating them as one vertical among several.
04
Evidence Platform Experience
Our real world evidence and registry work covers the longitudinal data collection PMCF obligations increasingly require.
05
Validated System Delivery
We produce Part 11 validation evidence as a work product rather than assembling documentation before an audit.
06
Certified Security Posture
ISO 27001 certification means security controls are documented and auditable, supporting manufacturer vendor assessment efficiently.
Pricing
Medical device post-market surveillance pricing depends on portfolio size, data source count, whether PMCF data collection is in scope, and validation depth. PMCF study support is frequently the largest component where existing evidence is insufficient and active collection is required. Discovery produces an itemized, fixed-scope estimate with phase-level breakdown. Literature database subscriptions, registry fees, and cloud infrastructure are separate from engineering cost.
MVP or Single Module
An MVP covering trend monitoring and plan tracking typically runs $40,000 to $80,000 for a focused product family.
Full Platform Build
A full platform with multi-source integration, literature workflow, and reporting support typically falls between $80,000 and $200,000.
Enterprise Deployment
Enterprise engagements covering portfolio surveillance, PMCF collection, and full validation start at $200,000.
Discovery Phase Scoping
Discovery is a paid, time-boxed phase producing an itemized estimate, architecture plan, and plan execution gap assessment.
Cost Drivers to Expect
PMCF scope, portfolio size, data source count, and validation depth are the largest variables, identified during discovery.
Ongoing Support Costs
Post-launch regulatory changes, source additions, and support are quoted separately as a retainer sized to portfolio breadth.
Get Started
If you are evaluating medical device post-market surveillance software for PMS plan execution, trend monitoring, literature workflow, or PMCF data collection, the fastest next step is a discovery call with our team. We will compare plan commitments against execution evidence and return an itemized, fixed-scope estimate. Contact us to schedule that conversation.
FAQs
Frequently Asked Questions
Quality and regulatory leaders evaluating medical device post-market surveillance software usually ask how this differs from complaint handling, what notified bodies actually examine, and whether PMCF requires new data collection. The answers below reflect how we scope these projects.
Direction. Complaint systems process reports that arrive; surveillance actively seeks evidence about real-world performance through literature, registries, trend analysis, and clinical follow-up. A device with few complaints still requires surveillance, since absence of complaints is not evidence of performance.
Whether the PMS plan was executed. Plans commit to specific activities, sources, and frequencies, and the common finding is that committed activities cannot be evidenced. The plan document being well written does not help if nobody can show the monitoring actually occurred.
Where existing evidence is insufficient to confirm performance and safety, yes. That may mean registry participation, structured follow-up, or a study. PMCF is a data collection obligation rather than an analysis exercise, which is the part organizations most frequently underestimate.
An MVP covering trend monitoring runs $40,000 to $80,000. A full platform typically falls between $80,000 and $200,000. Enterprise deployments with PMCF collection start at $200,000. PMCF scope drives cost more than portfolio size.
With quality and clinical input, balancing sensitivity against noise. Thresholds set too tight generate review burden without signal; too loose defeats the purpose. Threshold exceedance may also carry its own reporting obligation, so the definition has regulatory weight beyond operations.
It can surface patterns and threshold exceedances for assessment. Whether a pattern constitutes a genuine safety signal, and what it means clinically, is determined by qualified personnel. Statistical detection and clinical significance are different questions, and only the first is automatable.