ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA

admin December 16th, 2017 Posted by Orcanos Team( ) ISO 13485, ISO 14971, Requirements Management Tool, RISK Assessment, Risk Management, Safety

ORCANOS released a new RISK management system (ISO 14971), based on recent RECALL CLASS 1 by the FDA, to include RISK analysis covering recent incident of potential flammability of battery used by the device. The new release includes also mitigation procedure for that case as well.

Hazard: Battery overheated on the device unit while charging in standby mode during a routine procedure

Failure Cause: Manufacturing Failure

Failure Effect/ Harm: System flammability causing fire or wrong function

Risk Control (RISK-2277): Register for the free trial on: https://lnkd.in/ghv8YX6

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Related Links

Risk Management

Quality Management

Document Control Software (ISO 13485)

What is ISO 14971

 


About the author, Orcanos Team

Orcanos software was founded on 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides an integrated software for ALM (Design Control) and Quality management (QMS), combined with regulations compliance, specializes in the medical device industry. 

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