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Risk managment 208 - Coggle Diagram
Risk managment 208
Risk type
Top down
extrernal factors
People. property, environment
Design failure modes
Exisitng faults
Engineering related
Usability failure nodes
Scenario
209 and 209 B
Reasonably foreesable missuse
Process failure modes
not included in risk mangement
Responsibilty of manufacturer
ID
53 main categories
HZ
208 F
SFC single fault conditions
PRMP
Team
Multi dep.
208-C
Control measures
208-D
208-G
harms
1-5(death)
4-5 reportable to MHRA
HA
208-H
Sect 5 Risk acceptability table
NACC
Risk/benefit
ACC
Risk evaluation
Severity
Probability
Consult PRM
end user
clinical
OT
Sales
PMS
Complaints
Non Conformity
Risk control
Design
Protect
Warn
IFU
Labelling
If only in IFU but no label DOESN'T reduce risk - need lable on product
14971:2019
Risk management stanadard
All std refer back to this
ISO 13485
Regulatory req. med devices
Not reg. yet
Risk
Probability
Harm
severity
501
Complaint handling procedure
PMS
MDR
GSPR
ISO 9001
Reg to this level
QAM
Accora policy
Based on 13485
6061
Essential performance
Not in Accora products
In risk matrix
Mitigated through alarn or power back up
State of art
Look at other products on the market