A key for each medical device company is: Keeping up with changes to ISO 13485:
” specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

Also:

ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Medical device companies must have established risk management processes that comply with ISO 14971.

Some keys for each company to set up a risk management process:
they must come up with list of risks, then apply Risk analysis method:
(for example) FMECA=Failure Mode, Effects and Criticality Analysis, then they must come up with a planned solution to handle each risk, or APQP= Advanced Product Quality Planning and Control

finally they must check the effectiveness for each solution (measurement).

https://www.iso.org/standard/59752.html