Medical  Device  &  QA  Consultancy

HAZARD IDENTIFICATION and RISK ANALYSIS.......

.....is Central to any successful Medical Device Strategy..... no matter what the class....

   
The Standard to be applied is EN ISO 14971:2001 which covers;

Risk Analysis; Risk Evaluation; Risk Control; Post Production Input into the Process.

The Steps in the process include:
 
· Identifying ALL potential HAZARDS
à Consider QUALITATIVE and QUANTITATIVE aspects
· Analyse the RISK associated with each identified HAZARD
à Estimate the LIKELIHOOD of occurrence of each identified HAZARD
à Estimate the SEVERITY/CRITICALITY when each HAZARD occurs
 
· Tabulate the RESULTS· REVIEW and APPROVE and ISSUE the Results
§ HAZARD Identification and associated RISK ANALYSIS is an ONGOING and
CONTINUOUS PROCESS.

 

· Generating the following documents;

A Risk Management Plan;
A Risk Management File;
A Risk Management Summary.

 

· Make the following Links to your ISO 9001:2000 and/or ISO 13485:2003 Quality System;
 
Management Responsibilities;
          Design and Development Control;
Post Production Feedback / Post Market Surveillance processes.
         
 

To find out more about how we can help you effectively MANAGE the RISKS associated with your Product,

feel free to CONTACT US for help with any Medical Device Issue 

 

 

 

 

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