In the current company I work at, we identify risks through a PHMM or Product Hazard and Mitigation Matrix. In these meetings you have directors from R&D, Quality, Manufacturing, and the Medical d...

Some other tools that I have seen used in risk management is root cause analysis. This allows us to pinpoint the factor or cause of the failure to help resolve and analyze how to stop it, how to preve...

Risk management is the process of analyzing, identifying and responding to risk factors. Managing risks early is the best way to avoid issues later on. Throughout the R&D stage, applying the right...

Design review meetings consist of many things. They review updates and changes that may be necessary and make a decision on said decision. Usually in these meetings you have a representative from each...

I actually just wrote and performed both verification procedures as well as validations for the current company I work at. FDA does not mandate a specific way verifications are performed, they just ma...

Meeting minutes are a very important part of the design change process of the device and development as well. It depends what stage you are in the the medical device development cycle, that certainly ...

I agree as well with the comment above, that if to choose a certain aspect that is important in the design development plan, the scope management plan is quite important. This details the ideas of the...

The reason design controls fails is because either procedures are not followed or the procedures themselves are poorly written, and the planning of every aspect of the device and documentation is poor...

To add to the previous response, design verifications and design validations are very similar however, design verifications verify the design inputs and outputs. Design validations check that the user...