Description:
This Trend Analysis tool supports structured trend reporting in PMS by calculating year-by-year incident rates and highlighting significant changes against predefined acceptance criteria.

• Track incident rates year by year for IMDRF code sets used in PMS summaries.

• Evaluate curve slopes of trendlines to identify statistically meaningful changes.

• Apply configurable acceptance criteria (5%/10%) aligned to the PMS plan.

• Flag significant trends beyond “X%” and support documentation of corresponding corrective actions.

• Support analysis of non-serious incidents and known undesirable side-effects described in labeling.

Your needs:

• Trend analysis tool

• Trend analysis tool for MDR compliance

• Improve PMS signal detection, reduce rework, and strengthen audit readiness.

Use this tool when compiling PMS outputs (e.g., PSUR inputs) to quantify changes over time and document whether trends exceed defined thresholds.

It focuses on consistent interpretation. Curve slope is the direction and magnitude of change in incident rate over time; it matters because it turns raw counts into a decision-ready signal. Acceptance criteria define what “significant” means in your PMS plan; it matters because it standardizes escalation.

• Define device scope and the monitoring period.

• Calculate incident rates per selected IMDRF codes.

• Apply the defined 5%/10% (or device-specific) acceptance threshold.

• Identify significant increases beyond “X%” and document rationale.

• Record resulting actions (e.g., CAPA initiation or continued monitoring).

At Lexqara, we help you operationalize PMS analytics, connect trend outputs to PSUR narratives, and link signals to complaint handling and CAPA decision-making. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. IMDRF adverse event terminology [https://www.imdrf.org/working-groups/adverse-event-terminology]. Download the template or request a short gap assessment.