Risk Management, FMEA and ISO 14971

Rami.Azulay April 3rd, 2011 Posted by Rami Azulay( ) ISO 14971, Risk Management

The risk management standard required by medical device manufacturers is ISO 14971.

The ISO14971 talks about risk management plan, risk management file, risk analysis, risk evaluation, risk control, production and post production, verification methods and more.

The FMEA (Failure Mode Effect Analysis) or FMECA (Failure Mode Effect Cause Analysis) is an acceptable risk management application that supports some parts described in ISO 14971.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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