"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.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!