Services: Medical Device Risk Analysis & Risk Management
The need for Medical Device Risk Analysis and Management is pervasive. QA Consulting, Inc. has developed solutions to address the ISO 14971:2007 requirements for risk planning, risk management, and reduce risk to an “acceptable” level as determined by each client. We understand that each situation is unique and therefore customize traditional risk analysis methods such as fault tree analysis (FTA) and failure mode effect analysis (FMEA) for the situation.
- Risk Planning
- Hazard Analysis
- Failure Mode Effect Analyses
An example is shown by the color coded FTA below. Each color represents a system element or subsystem which clarified interactions and “unblocked” the thinking process allowing completion of the software and system level FMEAs.
