A mandatory and integral part of any medical device development
Risk management during the entire device development cycle is a mandatory requirement for domestic as well as international regulatory compliance. The implementation of risk management on procedural and operational level does not have to impose an undue additional burden. If correctly applied, risk management ensures a more efficient development process and reduces product life-cycle cost.
SystemSafety,Inc. has extensive experience in implementing and executing a streamlined risk management processes. Depending on your already established operating procedure framework we are able to integrate a compliant risk management lifecycle into your development process.
Example of a partial IEC 601-1-4 risk management checklist (PDF)
Example of a partial ISO 14971 risk management checklist in (PDF)
For more information see Methodologies :: Risk Analysis