DOWNSTREAM ServiceS
09. Post-Market Surveillance (PMS)
Transform reactive compliance into proactive innovation. By deploying systematic surveillance that distinguishes between malfunction and use error, we ensure your post-market data doesn't just sit in a file - it fuels the roadmap for your next generation of technology.
CLOSE THE LOOP.
“The launch is not the finish line; it is the ultimate validation. We mine real-world usage patterns to turn today’s user workarounds into tomorrow’s breakthrough features.”
KEY OUTPUTS & DELIVERABLES
Proactive PMS Planning
Developing EU MDR-compliant strategies that actively seek out real-world user data.
User Survey Design & Execution
Deploying large-scale surveys to capture clinical feedback and safety signals directly from the field.
Clinical Evaluation Report (CER) Updates
Integrating proactive data into your clinical evidence record to maintain market access.
Safety Signal Detection
Identifying emerging trends in use behavior before they escalate into systematic hazards.
09.a
Proactive PMS Surveys
Active safety monitoring to satisfy global compliance.
Under EU MDR, passive monitoring is no longer sufficient. We design and deploy proactive surveillance systems to measure user satisfaction, identify low-frequency use errors, and validate real-world performance. We ensure your device is performing as intended across the general population to provide the data necessary for continuous safety updates.
KEY OUTPUTS & DELIVERABLES
Use Error vs. Device Failure Categorization
Specialist analysis to correctly identify human factors issues versus mechanical malfunctions.
Root Cause Analysis (RCA)
In-depth investigation of adverse events to identify cognitive or physical triggers in the user interface.
Trend Analysis & Threshold Monitoring
Statistical tracking of use-related issues to trigger proactive design or instructional interventions.
Periodic Safety Update Reports (PSUR)
Authoring comprehensive safety summaries for regulatory bodies that reflect the actual use-risk profile.
09.b
Complaint Analysis & Root Cause Investigation
Distinguishing between mechanical failure and use error.
We move beyond superficial reporting to find the true root cause of clinical issues. By analyzing complaint narratives, we distinguish between a "broken part" and a "broken workflow." We update your Risk Management File with real-world frequency data, keeping your technical documentation living, accurate, and defensible.
KEY OUTPUTS & DELIVERABLES
"Workaround" Identification
Documenting how users improvise or bypass design features to meet clinical needs.
Next-Gen Requirement Gap Analysis
Translating post-market frustrations into high-value engineering inputs for Version 2.0.
Competitive Performance Benchmarking
Comparing real-world user feedback against market incumbents to identify areas for differentiation.
Feature Prioritization
Data-backed recommendations for R&D roadmaps based on quantified user pain points.
09.c
Next-Gen Opportunity Mining
Transforming today’s complaints into tomorrow’s features.
Your current device’s "friction points" are the blueprint for your next generation. We mine post-market data to identify unmet needs, clinical workarounds, and feature gaps. These insights feed directly back into the Strategy & Innovation phase to ensure that the end of one product cycle is the evidence-based beginning of the next.
The Strategic Outcome
Circular Intelligence.
Continuous Innovation.
The ‘Post-Market Surveillance’ services ensure that the "Launch" is only the beginning of your product's success. We close the loop between downstream data and upstream strategy, ensuring you never make the same mistake twice. By turning reactive compliance into proactive intelligence, we protect your current market position while building the evidentiary foundation for your next-generation technology.
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Exploring Downstream Phase