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?

That's the healthiest approach with the QMS. Not only look at the regulations, points and commas, but also at the people and the balance book. This way it is an active part of the whole organisation, which adds to the well-being of all, including the CEO and CFO. And this way it becomes clear that the complete QMS is relevant to all.