An Example of a Risk Analysis Report for a Class II Medical Device (Oxygen Mask)

sagai

Quite Involved in Discussions
#11
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

yes one more thing.
Risk Management Report and the Risk Management file are not the same.
Szabolcs
 
Elsmar Forum Sponsor
A

aAlexanderL

#12
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

I think that is exactly what I am looking for. A very helpful attachment!
 
O

ocarvajal

#13
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

hello, thanks.
I hope enjoy this site.

Have a good day
Oscar
 
N

Network_Services

#14
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

All I can say is "thank you" again. Was lucky to stumble across this forum. Never knew it existed. You've been very helpful.
Same here!

It has helped with a new venture I have embarked upon :D
 
V

Vidarv

#15
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

i am unable to download the sample risk analysis file. any chance you can upload it again..will b very grateful
vidarv
 

harry

Super Moderator
#16
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

i am unable to download the sample risk analysis file. any chance you can upload it again..will b very grateful
vidarv
Welcome to the Cove.

Which particular post are your referring to? Post #4, #9 or #10? I've just checked and they can all be opened or downloaded.
 
V

Vidarv

#17
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Thankyou:)...I did mange to open the risk ananlysis doc...looks more like a risk management file....I am actually after a format for generating a final consolidated risk analysis report and fmea report for a registration....any help will be greatly appreciated...btw this forum is awesome....
 

harry

Super Moderator
#18
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Thankyou:)...I did mange to open the risk ananlysis doc...looks more like a risk management file....I am actually after a format for generating a final consolidated risk analysis report and fmea report for a registration....any help will be greatly appreciated...btw this forum is awesome....
For better response, I recommend you to start a new thread rather than piggy back on one whose title doesn't reflect what you want.
 
C

CLEHillBilly

#19
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Hi, Just wanted to say THANK YOU for the sample Bubble Humidifier report in post #10 from SteveK.

Since I stumbled on this forum 2 weeks ago its really helped me understand what our small 5 person company needs for ISO 14971.

With that report I hope to use our FMEA to populate the sample report.

Thanks,
CLEHillBilly
 
I

immaya08

#20
Re: A sample of a Risk Analysis Report - Class II Medical Device (Oxygen Mask)

Hi,

using HACCP as the tool for med device risk assessment; i gather that documentation would include as follows : (based on ISO 14971 requirements)Risk Management Plan: contains the scope; description of the med device and its intended use with characteristics identified; responsibilities and authorities (pertaining risk management process); criteria for risk acceptability, including activities (and results of such) as: hazard id and analysis, risk analysis/assessment including risk estimation, risk control analysis, risk control options analysis; while the rest could be part of the Risk Management Report - implementation of risk control measures, residual risk evaluation; both risk management plan and report are included in the risk management file
 
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