Summary of clause 4 General requirements
Requirements
Establish, implement, document and maintain a process
Apply this process throughout the life cycle
Understand the elements of the process
Understand the appropriate parts of the process Address risks
Check the compliance of the process Address risks
Provide evidence of top management commitment to the Address risks process
Define and document policy (regarding top management)
Provide a framework (regarding policy)
Take into account the available information (regarding the policy)
Check the adequacy of the Address risks process at defined intervals (regarding top management)
Document any decisions made (regarding top management)
Check policy compliance
Recruit competent staff
Develop the necessary knowledge and experience
Maintain records (objective evidence)
Check skills compliance
Plan process activities to manage risks
Establish a risk management plan
Document a risk management plan
Include the risk management plan in the risk management file
Save plan changes
Create and update the risk management file
Enable traceability for each identified hazard
Process 
Address MD risks
Procedures 
DM Risk Management
Instructions 
Risk support
List of risks
Risk policy
Process review Address risks
Decisions and actions
Risk management plan
Accompanying documentation
Risk management file
Address risks process sheet
Post-market monitoring process sheet
Process sheet Evaluate the benefit/risk ratio
Risk analysis activities
Risk evaluation activities
Control measures
Benefit-risk ratio
Review of control measures
Completeness review
Risk management report
PMMP plan (post-market monitoring plan)
PMMR report (post-market monitoring report)
List of information collected
Review of collected information