Case study · Risk system
Predictive Risk Assessment Framework
An ISO 14971-aligned risk quantification and management pipeline for early-stage MedTech product development. It integrates risk-register data, severity and probability scoring, and mitigation tracking in a reproducible workflow, embedded in Heagital’s regulatory pathway.
Pattern-based scoring
Audit trail
Decision gates
ISO 14971
The decision
Point-of-care device development carries risk from the very first stages. Heagital needed a structured, auditable way to assess that risk early, in step with the medical-device standard it has to meet.
The approach
The framework scores risk using pattern-based logic, records every step in an audit trail, and routes the project through explicit decision gates. It is aligned to ISO 14971 and embedded directly in Heagital’s regulatory pathway, so risk assessment is part of the workflow rather than a separate exercise.
The outcome
A repeatable, standards-aligned risk process that produces a defensible trail from early signals to go / no-go decisions, built into the company’s regulatory pathway.
Technologies used
Python · ISO 14971 · MedTech
Insight 