Video FAQs

Who decides what residual risks should be listed and could the NB push for a specific risk?

"At the end of the process, the NB issues a certificate, but it's the manufacturer who signs the DOC and it is the manufacturer's responsibility to define what is appropriate. The manufacturer knows the device and intended population the best, but the information must be clearly documented in the risk management process for review by the NB. The NB may raise a gap identified in the review process and push to add a residual risk, and that will need to be resolved with the manufacturer during the Q&A process.

One factor in ensuring your risk assessment is comprehensive is to utilize a cross functional team to appropriately identify and agree on residual risks. It cannot be done effectively with just a risk manager or just a clinical person - it takes a team.