Structure a Risk Management File

 

The growth within the medical device usage has caused growth a complexity of making the medical device secure for human use. threat control process want to set up by the medical device manufacturer to make sure tool protection, usability & regulatory compliance. medical device producer shall set up, put into effect, record and preserve an ongoing risk management system all through the life of a medical device. 

chance control is a systematic technique of identifying the hazards, evaluating the dangers, controlling the danger and monitoring all kinds of dangers at all levels of the product realization beginning from raw fabric to put up production interest as in keeping with the same old ISO 14971:2019. As such, ISO 14971 is recounted by FDA in the 21 CFR part 820 QSR for medical gadgets.all of the hazard management hobby and statistics are captured inside the hazard management record.

Risk Management process include the following elements: 

• Risk Management Plan 
• Risk Analysis 
• Risk Evaluation 
• Risk Control 
• Evaluation of overall residual risk acceptability 
• Risk Management review 
• Production and post production information 

risk management file offer a traceability among every diagnosed risk to the threat analysis, the hazard assessment, Implementation & verification of danger control measures, the consequences of the assessment of residual dangers.

medical tool producer want to prepare following files which covers the complete chance control requirements as in keeping with ISO 14971:2019.

• Risk Management Plan 
• Preliminary Hazard Analysis 
• Design Failure Mode Effect Analysis 
• Process Failure Mode Effect Analysis 
• Application Failure Mode Effect Analysis 
• Risk Benefit Analysis 
• Risk Management File & Report 

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