Industry solutions
Medical Devices
Risk management is a lifecycle, not a deliverable.
A medical device's risk file lives as long as the device does: hazards identified before design freeze, risk controls implemented and verified, residual risk weighed against benefit — and production and post-production data feeding it all back. RAMSynapse keeps that file connected and current, from the first hazard analysis to post-market surveillance.
The risk management file fragments
Hazard analysis in one document, FMEAs in spreadsheets, harm traceability rebuilt by hand — before every audit and every submission, someone reassembles the file from pieces.
Design changes orphan the risk analysis
Every design iteration shifts failure modes and probabilities; analyses that were copied instead of linked go stale — and ISO 14971 expects the file to stay current.
Post-market data never reaches the file
Complaints and CAPA live in the QMS while the risk analysis sits frozen at release — yet the standard expects post-production information to re-open the risk evaluation.
The regulatory landscape
The standards, and the modules that carry them.
ISO 14971
Application of Risk Management to Medical Devices
Hazard identification, risk estimation, risk control and residual-risk evaluation — maintained across the total lifecycle, with post-production data flowing back into the analysis.
IEC 62304
Medical Device Software — Software Life Cycle Processes
Software safety classification driven by the hazard analysis: the class a software item carries decides the rigour of its entire lifecycle, so the risk work has to come first.
IEC 60601-1
Medical Electrical Equipment — Basic Safety and Essential Performance
Single-fault safety and means of protection for electrical medical equipment, with the ISO 14971 risk process built into the standard's own acceptance logic.
FDA 21 CFR 820
Design Controls
Design inputs, outputs, verification and validation traced through the design history file — with risk analysis required inside design validation and CAPA closing the loop.
A device-typical chain
One model, every analysis.
How a device programme keeps ISO 14971 risk management live on one system model — each result feeding the next analysis, never retyped.
- Identify hazards, estimate riskFHAHazards, hazardous situations and harms enumerated per ISO 14971; each risk estimated from severity and probability of occurrence of harm — the top of the file.
- 02Select and assign risk controlsInherent safety by design, then protective measures, then information for safety — in that order, with every control traced to the risk it is claimed to reduce.
- Run the design FMEAFMECAFailure modes evaluated for the hazardous situations they can trigger; occurrence rankings tied to real failure rates instead of committee estimates.
- Quantify the harm scenariosFault TreeFault trees on the sequences leading to harm, quantified with controls in place — residual-risk numbers the risk management report can actually defend.
- Close the post-market loopFRACASComplaints, servicing and production data flow back through FRACAS; observed rates re-open the risk evaluation and keep the file honest for its whole life.
Bring the auditor a living risk file.
See how a device programme runs hazard analysis, risk controls, FMEA, fault trees and post-market surveillance on one shared system model — on your own infrastructure.