All,
We are a medical device facility under the guidelines of ISO 13485:2003 as well as FDA scrutiny (ISO 14971). With that said, I am also interested in preventing the risk management system from just being used for Quality and Regulatory purposes. Does anyone use / have forms that not only address a risk through QA/RA, but have found a way to incorporate $$ into the risk assessment.
Our systems are segmented here - I am not here to blame but our software package is very restrictive. Recently, I have taken this over. However, realized that once this is complete and the design is released it is not used for a comparative analysis against the development costs, ongoing QA, future development projects other than to create another risk assessment for a new project.
I am referring to the entire Risk Management including questionnaires, FMEA's, etc..
Any thoughts?
We are a medical device facility under the guidelines of ISO 13485:2003 as well as FDA scrutiny (ISO 14971). With that said, I am also interested in preventing the risk management system from just being used for Quality and Regulatory purposes. Does anyone use / have forms that not only address a risk through QA/RA, but have found a way to incorporate $$ into the risk assessment.
Our systems are segmented here - I am not here to blame but our software package is very restrictive. Recently, I have taken this over. However, realized that once this is complete and the design is released it is not used for a comparative analysis against the development costs, ongoing QA, future development projects other than to create another risk assessment for a new project.
I am referring to the entire Risk Management including questionnaires, FMEA's, etc..
Any thoughts?