Experience with Risk Management in Jama
Dear Jama users,
We are currently using Jama as part of medical device development, i.e., for risks, requirements, verification and validation.
We currently use a highly customized meta model for Risk Management, while giving traceability it has its shortcomings when it comes to maintainability. The implementation has separate items for causes, risks, residual risks, hazards, harms, risk control measure (which is also duplicated in one or more requirements). In addition it relies on a custom velocity report that is similar to the table layout you have in an excel spreadsheet for risk management.
We are now looking into approving our Jama approach for risk management and would benefit from other user's learnings.
Does anybody have some learnings they can share? E.g., using Jamas fairly new risk management meta model for medical devices or their own custom implementation (conforming to ISO 14971).
Thank you!