I believe, if first starting up a company, such as a start up and do not want to have the corporate feel to the company, I believe an organic organization structure makes the most sense to start off. You have…   Read more»

In my current company, the organization type is a mix between functional and a project based organization. There are individual departments ranging from Hardware Eng, Quality, Software Eng, Systems Eng, Marketing, and Manufacturing. There certainly are silos, but for those…   Read more»

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 director discuss the potential applicable product risk management…   Read more»

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 prevent it…   Read more»

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 department, such as Quality, Regulatory, Marketing, and…   Read more»

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 mandate in their 510k or PMA submissions that…   Read more»

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 dictates the importance of the meeting…   Read more»

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 medical device and each…   Read more»

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. However, in a medical device industry that rarely…   Read more»

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 required specifications are met, and the that the medical device is…   Read more»